🔍 RecallPedia

Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U

Class I - Dangerous
🏥 Medical Devices Recalled: April 29, 2024 ARROW INTERNATIONAL Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    a) REF IAB-06830-U, UDI: (01)10801902161939(17)240731(10)18F22H0008, (01)10801902161939(17)241130(10)18F22M0019, (01)10801902161939(17)241231(10)18F23A0027, (01)10801902161939(17)241231(10)18F23A0039, (01)10801902161939(17)250131(10)18F23B0006, (01)10801902161939(17)250131(10)18F23B0020, (01)10801902161939(17)250131(10)18F23B0032, (01)10801902161939(17)250630(10)18F23G0066, (01)10801902161939(17)250731(10)18F23H0059, (01)10801902161939(17)250731(10)18F23H0070, (01)10801902161939(17)250731(10)18F23H0074, (01)10801902161939(17)250831(10)18F23J0046, (01)10801902161939(17)250930(10)18F23K0059, (01)10801902161939(17)251231(10)18F24A0036, (01)10801902161939(17)260331(10)18F24D0004, (01)10801902172898(17)240430(10)18F22E0062, (01)10801902172898(17)240531(10)18F22F0007, (01)10801902172898(17)240531(10)18F22F0017, (01)10801902172898(17)240531(10)18F22F0020, (01)10801902172898(17)240531(10)18F22F0034, (01)10801902172898(17)240531(10)18F22F0045, (01)10801902172898(17)240531(10)18F22F0057, (01)10801902172898(17)240630(10)18F22G0001, (01)10801902172898(17)240630(10)18F22G0004, (01)10801902172898(17)240630(10)18F22G0007, (01)10801902172898(17)240630(10)18F22G0014, (01)10801902172898(17)240731(10)18F22H0002, (01)10801902172898(17)240731(10)18F22H0024, (01)10801902172898(17)240731(10)18F22H0029, (01)10801902172898(17)240731(10)18F22H0034, (01)10801902172898(17)240831(10)18F22J0009, (01)10801902172898(17)250430(10)18F23D0029, (01)10801902172898(17)250430(10)18F23E0037, (01)10801902172898(17)250430(10)18F23E0038, (01)10801902172898(17)250531(10)18F23E0033, (01)10801902172898(17)250531(10)18F23E0057, (01)10801902172898(17)250531(10)18F23F0023, (01)10801902172898(17)250531(10)18F23F0045, (01)10801902172898(17)250630(10)18F23G0025, (01)10801902172898(17)250630(10)18F23G0026, (01)10801902172898(17)250630(10)18F23G0051, (01)10801902172898(17)250731(10)18F23G0067, (01)10801902172898(17)250731(10)18F23H0009, (01)10801902172898(17)250731(10)18F23H0025, (01)10801902172898(17)250731(10)18F23H0028, (01)10801902172898(17)250731(10)18F23H0069, (01)10801902172898(17)250731(10)18F23H0080, (01)10801902172898(17)250831(10)18F23H0011, (01)10801902172898(17)250831(10)18F23J0004, (01)10801902172898(17)250831(10)18F23J0011, (01)10801902172898(17)250831(10)18F23J0015, (01)10801902172898(17)250831(10)18F23J0053, (01)10801902172898(17)250831(10)18F23J0054, (01)10801902172898(17)250831(10)18F23J0055, (01)10801902172898(17)250930(10)18F23J0079, (01)10801902172898(17)250930(10)18F23K0003, (01)10801902172898(17)250930(10)18F23K0005, (01)10801902172898(17)250930(10)18F23K0009, (01)10801902172898(17)250930(10)18F23K0051, (01)10801902172898(17)250930(10)18F23K0061, (01)10801902172898(17)251031(10)18F23L0040, (01)10801902172898(17)251130(10)18F23M0002, (01)10801902172898(17)251130(10)18F23M0044, (01)10801902172898(17)251130(10)18F23M0049, (01)10801902172898(17)251130(10)18F23M0053, (01)10801902172898(17)251130(10)18F23M0054, (01)10801902172898(17)251231(10)18F23M0055, (01)10801902172898(17)251231(10)18F24A0006, (01)10801902172898(17)251231(10)18F24A0012, (01)10801902172898(17)251231(10)18F24A0013, (01)10801902172898(17)251231(10)18F24A0021, (01)10801902172898(17)260131(10)18F24B0014, (01)10801902172898(17)260228(10)18F24C0004, (01)10801902172898(17)260228(10)18F24C0005, (01)10801902172898(17)260331(10)18F24D0033, (01)10801902172898(17)260331(10)18F24D0036, (01)10801902172898(17)260331(10)18F24D0043, (01)10801902172898(17)260331(10)18F24D0048, (01)10801902172898(17)260331(10)18F24D0086; b) REF IAB-06840-U, UDI: (01)10801902161946(17)240430(10)18F22E0023, (01)10801902161946(17)240531(10)18F22F0009, (01)10801902161946(17)240531(10)18F22F0019, (01)10801902161946(17)240731(10)18F22H0014, (01)10801902161946(17)240731(10)18F22H0028, (01)10801902161946(17)240731(10)18F22H0036, (01)10801902161946(17)241130(10)18F22M0015, (01)10801902161946(17)241231(10)18F23A0019, (01)10801902161946(17)241231(10)18F23A0037, (01)10801902161946(17)241231(10)18F23A0054, (01)10801902161946(17)241231(10)18F23A0055, (01)10801902161946(17)241231(10)18F23A0061, (01)10801902161946(17)250131(10)18F23A0066, (01)10801902161946(17)250131(10)18F23A0067, (01)10801902161946(17)250228(10)18F23A0025, (01)10801902161946(17)250228(10)18F23B0018, (01)10801902161946(17)250331(10)18F23D0018, (01)10801902161946(17)250430(10)18F23E0013, (01)10801902161946(17)250430(10)18F23E0015, (01)10801902161946(17)250630(10)18F23G0002, (01)10801902161946(17)250630(10)18F23G0003, (01)10801902161946(17)250630(10)18F23G0011, (01)10801902161946(17)250731(10)18F23G0063, (01)10801902161946(17)250731(10)18F23H0034, (01)10801902161946(17)250731(10)18F23H0035, (01)10801902161946(17)250731(10)18F23H0038, (01)10801902161946(17)250731(10)18F23H0053, (01)10801902161946(17)250731(10)18F23H0058, (01)10801902161946(17)250731(10)18F23H0071, (01)10801902161946(17)250831(10)18F23J0006, (01)10801902161946(17)250831(10)18F23J0008, (01)10801902161946(17)250831(10)18F23J0014, (01)10801902161946(17)250831(10)18F23J0018, (01)10801902161946(17)250831(10)18F23J0035, (01)10801902161946(17)250831(10)18F23J0042, (01)10801902161946(17)250930(10)18F23K0028, (01)10801902161946(17)260131(10)18F24B0025, (01)10801902161946(17)260131(10)18F24B0026, (01)10801902161946(17)260228(10)18F24C0151, (01)10801902161946(17)260331(10)18F24C0171, (01)10801902161946(17)260331(10)18F24C0177, (01)10801902161946(17)260331(10)18F24C0178, (01)10801902161946(17)260331(10)18F24C0179, (01)10801902161946(17)260331(10)18F24C0180, (01)10801902161946(17)260331(10)18F24C0195, (01)10801902161946(17)260331(10)18F24D0014, (01)10801902161946(17)260331(10)18F24D0017, (01)10801902161946(17)260331(10)18F24D0030, (01)10801902172904(17)240430(10)18F22E0001, (01)10801902172904(17)240430(10)18F22E0009, (01)10801902172904(17)240430(10)18F22E0014, (01)10801902172904(17)240430(10)18F22E0020, (01)10801902172904(17)240430(10)18F22E0036, (01)10801902172904(17)240430(10)18F22E0037, (01)10801902172904(17)240430(10)18F22E0042, (01)10801902172904(17)240430(10)18F22E0046, (01)10801902172904(17)240430(10)18F22E0048, (01)10801902172904(17)240430(10)18F22E0049, (01)10801902172904(17)240430(10)18F22E0061, (01)10801902172904(17)240430(10)18F22E0065, (01)10801902172904(17)240430(10)18F22E0066, (01)10801902172904(17)240531(10)18F22F0002, (01)10801902172904(17)240531(10)18F22F0010, (01)10801902172904(17)240531(10)18F22F0016, (01)10801902172904(17)240531(10)18F22F0021, (01)10801902172904(17)240531(10)18F22F0022, (01)10801902172904(17)240531(10)18F22F0037, (01)10801902172904(17)240531(10)18F22F0043, (01)10801902172904(17)240531(10)18F22F0047, (01)10801902172904(17)240531(10)18F22F0050, (01)10801902172904(17)240531(10)18F22F0051, (01)10801902172904(17)240531(10)18F22F0054, (01)10801902172904(17)240531(10)18F22F0065, (01)10801902172904(17)240531(10)18F22F0066, (01)10801902172904(17)240531(10)18F22F0067, (01)10801902172904(17)240531(10)18F22H0026, (01)10801902172904(17)240630(10)18F22G0067, (01)10801902172904(17)240731(10)18F22H0004, (01)10801902172904(17)240731(10)18F22H0010, (01)10801902172904(17)240731(10)18F22H0030, (01)10801902172904(17)240731(10)18F22H0038, (01)10801902172904(17)240731(10)18F22H0039, (01)10801902172904(17)240930(10)18F22K0004, (01)10801902172904(17)250228(10)18F23C0017, (01)10801902172904(17)250228(10)18F23C0027, (01)10801902172904(17)250228(10)18F23C0044, (01)10801902172904(17)250331(10)18F23D0015, (01)10801902172904(17)250331(10)18R23G0002, (01)10801902172904(17)250430(10)18F23D0027, (01)10801902172904(17)250430(10)18F23D0028, (01)10801902172904(17)250430(10)18F23E0014, (01)10801902172904(17)250430(10)18F23E0028, (01)10801902172904(17)250430(10)18F23E0035, (01)10801902172904(17)250430(10)18F23E0036, (01)10801902172904(17)250430(10)18F23E0050, (01)10801902172904(17)250430(10)18F23E0051, (01)10801902172904(17)250430(10)18F23E0052, (01)10801902172904(17)250531(10)18F23E0055, (01)10801902172904(17)250531(10)18F23F0003, (01)10801902172904(17)250531(10)18F23F0006, (01)10801902172904(17)250531(10)18F23F0007, (01)10801902172904(17)250531(10)18F23F0014, (01)10801902172904(17)250531(10)18F23F0015, (01)10801902172904(17)250531(10)18F23F0024, (01)10801902172904(17)250531(10)18F23F0025, (01)10801902172904(17)250531(10)18F23F0048, (01)10801902172904(17)250531(10)18F23F0052, (01)10801902172904(17)250531(10)18F23F0054, (01)10801902172904(17)250531(10)18F23F0059, (01)10801902172904(17)250630(10)18F23G0005, (01)10801902172904(17)250630(10)18F23G0007, (01)10801902172904(17)250630(10)18F23G0014, (01)10801902172904(17)250630(10)18F23G0028, (01)10801902172904(17)250630(10)18F23G0050, (01)10801902172904(17)250630(10)18F23G0053, (01)10801902172904(17)250731(10)18F23G0064, (01)10801902172904(17)250731(10)18F23G0065, (01)10801902172904(17)250731(10)18F23H0057, (01)10801902172904(17)250731(10)18F23H0075, (01)10801902172904(17)250831(10)18F23H0033, (01)10801902172904(17)250831(10)18F23J0019, (01)10801902172904(17)250831(10)18F23J0041, (01)10801902172904(17)250831(10)18F23J0050, (01)10801902172904(17)250930(10)18F23K0017, (01)10801902172904(17)250930(10)18F23K0018, (01)10801902172904(17)250930(10)18F23K0019, (01)10801902172904(17)250930(10)18F23K0027, (01)10801902172904(17)250930(10)18F23K0040, (01)10801902172904(17)250930(10)18F23K0045, (01)10801902172904(17)250930(10)18F23K0057, (01)10801902172904(17)251031(10)18F23K0060, (01)10801902172904(17)251031(10)18F23L0006, (01)10801902172904(17)251031(10)18F23L0029, (01)10801902172904(17)251031(10)18F23L0030, (01)10801902172904(17)251130(10)18F23M0019, (01)10801902172904(17)251130(10)18F23M0020, (01)10801902172904(17)251130(10)18F23M0037, (01)10801902172904(17)251130(10)18F23M0039, (01)10801902172904(17)251130(10)18F23M0040, (01)10801902172904(17)251130(10)18F23M0041, (01)10801902172904(17)251231(10)18F23M0064, (01)10801902172904(17)251231(10)18F23M0065, (01)10801902172904(17)251231(10)18F24A0002, (01)10801902172904(17)251231(10)18F24A0003, (01)10801902172904(17)251231(10)18F24A0004, (01)10801902172904(17)251231(10)18F24A0005, (01)10801902172904(17)251231(10)18F24A0014, (01)10801902172904(17)251231(10)18F24A0016, (01)10801902172904(17)251231(10)18F24A0022, (01)10801902172904(17)251231(10)18F24A0023, (01)10801902172904(17)251231(10)18F24A0024, (01)10801902172904(17)251231(10)18F24A0038, (01)10801902172904(17)260131(10)18F24B0006, (01)10801902172904(17)260131(10)18F24B0007, (01)10801902172904(17)260131(10)18F24B0023, (01)10801902172904(17)260131(10)18F24B0024, (01)10801902172904(17)260131(10)18F24B0027, (01)10801902172904(17)260131(10)18F24B0028, (01)10801902172904(17)260131(10)18F24B0045, (01)10801902172904(17)260131(10)18F24B0046, (01)10801902172904(17)260131(10)18F24B0047, (01)10801902172904(17)260131(10)18F24B0068, (01)10801902172904(17)260131(10)18F24B0069, (01)10801902172904(17)260228(10)18F24B0067, (01)10801902172904(17)260228(10)18F24B0070, (01)10801902172904(17)260228(10)18F24B0071, (01)10801902172904(17)260228(10)18F24C0006, (01)10801902172904(17)260228(10)18F24C0007, (01)10801902172904(17)260228(10)18F24C0028, (01)10801902172904(17)260228(10)18F24C0029, (01)10801902172904(17)260228(10)18F24C0030, (01)10801902172904(17)260228(10)18F24C0038, (01)10801902172904(17)260228(10)18F24C0092, (01)10801902172904(17)260228(10)18F24C0120, (01)10801902172904(17)260228(10)18F24C0121, (01)10801902172904(17)260228(10)18F24C0141; c) REF IAB-06850-U, UDI: (01)10801902144192(17)240831(10)18F22J0020(13)220916, (01)10801902144192(17)240831(10)18F22J0038(13)220928, (01)10801902144192(17)240831(10)18F22J0043(13)220930, (01)10801902144192(17)240930(10)18F22K0001(13)221003, (01)10801902144192(17)240930(10)18F22K0003(13)221004, (01)10801902144192(17)240930(10)18F22K0006(13)221006, (01)10801902144192(17)240930(10)18F22K0011(13)221007, (01)10801902144192(17)240930(10)18F22K0012(13)221007, (01)10801902144192(17)240930(10)18F22K0013(13)221007, (01)10801902144192(17)241231(10)18F23A0075(13)230131, (01)10801902144192(17)250131(10)18F23B0005(13)230203, (01)10801902144192(17)250131(10)18F23B0010(13)230206, (01)10801902144192(17)250131(10)18F23B0029(13)230220, (01)10801902144192(17)250131(10)18F23B0030(13)230220, (01)10801902144192(17)250228(10)18F23C0007(13)230307, (01)10801902144192(17)250228(10)18F23C0008(13)230307, (01)10801902144192(17)250228(10)18F23C0014(13)230310, (01)10801902144192(17)250228(10)18F23C0015(13)230310, (01)10801902144192(17)250531(10)18F23F0016(13)230609, (01)10801902144192(17)250531(10)18F23F0017(13)230609, (01)10801902144192(17)250831(10)18F23J0043(13)230921, (01)10801902144192(17)250831(10)18F23J0044(13)230923, (01)10801902144192(17)250930(10)18F23J0078(13)231031, (01)10801902144192(17)250930(10)18F23K0015(13)231031, (01)10801902144192(17)250930(10)18F23K0024(13)231014, (01)10801902144192(17)251031(10)18F23L0045(13)231130, (01)10801902144192(17)251130(10)18F23L0052(13)231205, (01)10801902144192(17)251130(10)18F23L0058(13)231205, (01)10801902144192(17)260131(10)18F24B0011(13)240209, (01)10801902144192(17)260131(10)18F24B0012(13)240209, (01)10801902172911(17)250831(10)18F23H0061(13)230911, (01)10801902172911(17)260131(10)18F24B0010(13)240207
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
ARROW INTERNATIONAL Inc.
Reason for Recall:
Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U

Product Codes/Lot Numbers:

a) REF IAB-06830-U, UDI: (01)10801902161939(17)240731(10)18F22H0008, (01)10801902161939(17)241130(10)18F22M0019, (01)10801902161939(17)241231(10)18F23A0027, (01)10801902161939(17)241231(10)18F23A0039, (01)10801902161939(17)250131(10)18F23B0006, (01)10801902161939(17)250131(10)18F23B0020, (01)10801902161939(17)250131(10)18F23B0032, (01)10801902161939(17)250630(10)18F23G0066, (01)10801902161939(17)250731(10)18F23H0059, (01)10801902161939(17)250731(10)18F23H0070, (01)10801902161939(17)250731(10)18F23H0074, (01)10801902161939(17)250831(10)18F23J0046, (01)10801902161939(17)250930(10)18F23K0059, (01)10801902161939(17)251231(10)18F24A0036, (01)10801902161939(17)260331(10)18F24D0004, (01)10801902172898(17)240430(10)18F22E0062, (01)10801902172898(17)240531(10)18F22F0007, (01)10801902172898(17)240531(10)18F22F0017, (01)10801902172898(17)240531(10)18F22F0020, (01)10801902172898(17)240531(10)18F22F0034, (01)10801902172898(17)240531(10)18F22F0045, (01)10801902172898(17)240531(10)18F22F0057, (01)10801902172898(17)240630(10)18F22G0001, (01)10801902172898(17)240630(10)18F22G0004, (01)10801902172898(17)240630(10)18F22G0007, (01)10801902172898(17)240630(10)18F22G0014, (01)10801902172898(17)240731(10)18F22H0002, (01)10801902172898(17)240731(10)18F22H0024, (01)10801902172898(17)240731(10)18F22H0029, (01)10801902172898(17)240731(10)18F22H0034, (01)10801902172898(17)240831(10)18F22J0009, (01)10801902172898(17)250430(10)18F23D0029, (01)10801902172898(17)250430(10)18F23E0037, (01)10801902172898(17)250430(10)18F23E0038, (01)10801902172898(17)250531(10)18F23E0033, (01)10801902172898(17)250531(10)18F23E0057, (01)10801902172898(17)250531(10)18F23F0023, (01)10801902172898(17)250531(10)18F23F0045, (01)10801902172898(17)250630(10)18F23G0025, (01)10801902172898(17)250630(10)18F23G0026, (01)10801902172898(17)250630(10)18F23G0051, (01)10801902172898(17)250731(10)18F23G0067, (01)10801902172898(17)250731(10)18F23H0009, (01)10801902172898(17)250731(10)18F23H0025, (01)10801902172898(17)250731(10)18F23H0028, (01)10801902172898(17)250731(10)18F23H0069, (01)10801902172898(17)250731(10)18F23H0080, (01)10801902172898(17)250831(10)18F23H0011, (01)10801902172898(17)250831(10)18F23J0004, (01)10801902172898(17)250831(10)18F23J0011, (01)10801902172898(17)250831(10)18F23J0015, (01)10801902172898(17)250831(10)18F23J0053, (01)10801902172898(17)250831(10)18F23J0054, (01)10801902172898(17)250831(10)18F23J0055, (01)10801902172898(17)250930(10)18F23J0079, (01)10801902172898(17)250930(10)18F23K0003, (01)10801902172898(17)250930(10)18F23K0005, (01)10801902172898(17)250930(10)18F23K0009, (01)10801902172898(17)250930(10)18F23K0051, (01)10801902172898(17)250930(10)18F23K0061, (01)10801902172898(17)251031(10)18F23L0040, (01)10801902172898(17)251130(10)18F23M0002, (01)10801902172898(17)251130(10)18F23M0044, (01)10801902172898(17)251130(10)18F23M0049, (01)10801902172898(17)251130(10)18F23M0053, (01)10801902172898(17)251130(10)18F23M0054, (01)10801902172898(17)251231(10)18F23M0055, (01)10801902172898(17)251231(10)18F24A0006, (01)10801902172898(17)251231(10)18F24A0012, (01)10801902172898(17)251231(10)18F24A0013, (01)10801902172898(17)251231(10)18F24A0021, (01)10801902172898(17)260131(10)18F24B0014, (01)10801902172898(17)260228(10)18F24C0004, (01)10801902172898(17)260228(10)18F24C0005, (01)10801902172898(17)260331(10)18F24D0033, (01)10801902172898(17)260331(10)18F24D0036, (01)10801902172898(17)260331(10)18F24D0043, (01)10801902172898(17)260331(10)18F24D0048, (01)10801902172898(17)260331(10)18F24D0086; b) REF IAB-06840-U, UDI: (01)10801902161946(17)240430(10)18F22E0023, (01)10801902161946(17)240531(10)18F22F0009, (01)10801902161946(17)240531(10)18F22F0019, (01)10801902161946(17)240731(10)18F22H0014, (01)10801902161946(17)240731(10)18F22H0028, (01)10801902161946(17)240731(10)18F22H0036, (01)10801902161946(17)241130(10)18F22M0015, (01)10801902161946(17)241231(10)18F23A0019, (01)10801902161946(17)241231(10)18F23A0037, (01)10801902161946(17)241231(10)18F23A0054, (01)10801902161946(17)241231(10)18F23A0055, (01)10801902161946(17)241231(10)18F23A0061, (01)10801902161946(17)250131(10)18F23A0066, (01)10801902161946(17)250131(10)18F23A0067, (01)10801902161946(17)250228(10)18F23A0025, (01)10801902161946(17)250228(10)18F23B0018, (01)10801902161946(17)250331(10)18F23D0018, (01)10801902161946(17)250430(10)18F23E0013, (01)10801902161946(17)250430(10)18F23E0015, (01)10801902161946(17)250630(10)18F23G0002, (01)10801902161946(17)250630(10)18F23G0003, (01)10801902161946(17)250630(10)18F23G0011, (01)10801902161946(17)250731(10)18F23G0063, (01)10801902161946(17)250731(10)18F23H0034, (01)10801902161946(17)250731(10)18F23H0035, (01)10801902161946(17)250731(10)18F23H0038, (01)10801902161946(17)250731(10)18F23H0053, (01)10801902161946(17)250731(10)18F23H0058, (01)10801902161946(17)250731(10)18F23H0071, (01)10801902161946(17)250831(10)18F23J0006, (01)10801902161946(17)250831(10)18F23J0008, (01)10801902161946(17)250831(10)18F23J0014, (01)10801902161946(17)250831(10)18F23J0018, (01)10801902161946(17)250831(10)18F23J0035, (01)10801902161946(17)250831(10)18F23J0042, (01)10801902161946(17)250930(10)18F23K0028, (01)10801902161946(17)260131(10)18F24B0025, (01)10801902161946(17)260131(10)18F24B0026, (01)10801902161946(17)260228(10)18F24C0151, (01)10801902161946(17)260331(10)18F24C0171, (01)10801902161946(17)260331(10)18F24C0177, (01)10801902161946(17)260331(10)18F24C0178, (01)10801902161946(17)260331(10)18F24C0179, (01)10801902161946(17)260331(10)18F24C0180, (01)10801902161946(17)260331(10)18F24C0195, (01)10801902161946(17)260331(10)18F24D0014, (01)10801902161946(17)260331(10)18F24D0017, (01)10801902161946(17)260331(10)18F24D0030, (01)10801902172904(17)240430(10)18F22E0001, (01)10801902172904(17)240430(10)18F22E0009, (01)10801902172904(17)240430(10)18F22E0014, (01)10801902172904(17)240430(10)18F22E0020, (01)10801902172904(17)240430(10)18F22E0036, (01)10801902172904(17)240430(10)18F22E0037, (01)10801902172904(17)240430(10)18F22E0042, (01)10801902172904(17)240430(10)18F22E0046, (01)10801902172904(17)240430(10)18F22E0048, (01)10801902172904(17)240430(10)18F22E0049, (01)10801902172904(17)240430(10)18F22E0061, (01)10801902172904(17)240430(10)18F22E0065, (01)10801902172904(17)240430(10)18F22E0066, (01)10801902172904(17)240531(10)18F22F0002, (01)10801902172904(17)240531(10)18F22F0010, (01)10801902172904(17)240531(10)18F22F0016, (01)10801902172904(17)240531(10)18F22F0021, (01)10801902172904(17)240531(10)18F22F0022, (01)10801902172904(17)240531(10)18F22F0037, (01)10801902172904(17)240531(10)18F22F0043, (01)10801902172904(17)240531(10)18F22F0047, (01)10801902172904(17)240531(10)18F22F0050, (01)10801902172904(17)240531(10)18F22F0051, (01)10801902172904(17)240531(10)18F22F0054, (01)10801902172904(17)240531(10)18F22F0065, (01)10801902172904(17)240531(10)18F22F0066, (01)10801902172904(17)240531(10)18F22F0067, (01)10801902172904(17)240531(10)18F22H0026, (01)10801902172904(17)240630(10)18F22G0067, (01)10801902172904(17)240731(10)18F22H0004, (01)10801902172904(17)240731(10)18F22H0010, (01)10801902172904(17)240731(10)18F22H0030, (01)10801902172904(17)240731(10)18F22H0038, (01)10801902172904(17)240731(10)18F22H0039, (01)10801902172904(17)240930(10)18F22K0004, (01)10801902172904(17)250228(10)18F23C0017, (01)10801902172904(17)250228(10)18F23C0027, (01)10801902172904(17)250228(10)18F23C0044, (01)10801902172904(17)250331(10)18F23D0015, (01)10801902172904(17)250331(10)18R23G0002, (01)10801902172904(17)250430(10)18F23D0027, (01)10801902172904(17)250430(10)18F23D0028, (01)10801902172904(17)250430(10)18F23E0014, (01)10801902172904(17)250430(10)18F23E0028, (01)10801902172904(17)250430(10)18F23E0035, (01)10801902172904(17)250430(10)18F23E0036, (01)10801902172904(17)250430(10)18F23E0050, (01)10801902172904(17)250430(10)18F23E0051, (01)10801902172904(17)250430(10)18F23E0052, (01)10801902172904(17)250531(10)18F23E0055, (01)10801902172904(17)250531(10)18F23F0003, (01)10801902172904(17)250531(10)18F23F0006, (01)10801902172904(17)250531(10)18F23F0007, (01)10801902172904(17)250531(10)18F23F0014, (01)10801902172904(17)250531(10)18F23F0015, (01)10801902172904(17)250531(10)18F23F0024, (01)10801902172904(17)250531(10)18F23F0025, (01)10801902172904(17)250531(10)18F23F0048, (01)10801902172904(17)250531(10)18F23F0052, (01)10801902172904(17)250531(10)18F23F0054, (01)10801902172904(17)250531(10)18F23F0059, (01)10801902172904(17)250630(10)18F23G0005, (01)10801902172904(17)250630(10)18F23G0007, (01)10801902172904(17)250630(10)18F23G0014, (01)10801902172904(17)250630(10)18F23G0028, (01)10801902172904(17)250630(10)18F23G0050, (01)10801902172904(17)250630(10)18F23G0053, (01)10801902172904(17)250731(10)18F23G0064, (01)10801902172904(17)250731(10)18F23G0065, (01)10801902172904(17)250731(10)18F23H0057, (01)10801902172904(17)250731(10)18F23H0075, (01)10801902172904(17)250831(10)18F23H0033, (01)10801902172904(17)250831(10)18F23J0019, (01)10801902172904(17)250831(10)18F23J0041, (01)10801902172904(17)250831(10)18F23J0050, (01)10801902172904(17)250930(10)18F23K0017, (01)10801902172904(17)250930(10)18F23K0018, (01)10801902172904(17)250930(10)18F23K0019, (01)10801902172904(17)250930(10)18F23K0027, (01)10801902172904(17)250930(10)18F23K0040, (01)10801902172904(17)250930(10)18F23K0045, (01)10801902172904(17)250930(10)18F23K0057, (01)10801902172904(17)251031(10)18F23K0060, (01)10801902172904(17)251031(10)18F23L0006, (01)10801902172904(17)251031(10)18F23L0029, (01)10801902172904(17)251031(10)18F23L0030, (01)10801902172904(17)251130(10)18F23M0019, (01)10801902172904(17)251130(10)18F23M0020, (01)10801902172904(17)251130(10)18F23M0037, (01)10801902172904(17)251130(10)18F23M0039, (01)10801902172904(17)251130(10)18F23M0040, (01)10801902172904(17)251130(10)18F23M0041, (01)10801902172904(17)251231(10)18F23M0064, (01)10801902172904(17)251231(10)18F23M0065, (01)10801902172904(17)251231(10)18F24A0002, (01)10801902172904(17)251231(10)18F24A0003, (01)10801902172904(17)251231(10)18F24A0004, (01)10801902172904(17)251231(10)18F24A0005, (01)10801902172904(17)251231(10)18F24A0014, (01)10801902172904(17)251231(10)18F24A0016, (01)10801902172904(17)251231(10)18F24A0022, (01)10801902172904(17)251231(10)18F24A0023, (01)10801902172904(17)251231(10)18F24A0024, (01)10801902172904(17)251231(10)18F24A0038, (01)10801902172904(17)260131(10)18F24B0006, (01)10801902172904(17)260131(10)18F24B0007, (01)10801902172904(17)260131(10)18F24B0023, (01)10801902172904(17)260131(10)18F24B0024, (01)10801902172904(17)260131(10)18F24B0027, (01)10801902172904(17)260131(10)18F24B0028, (01)10801902172904(17)260131(10)18F24B0045, (01)10801902172904(17)260131(10)18F24B0046, (01)10801902172904(17)260131(10)18F24B0047, (01)10801902172904(17)260131(10)18F24B0068, (01)10801902172904(17)260131(10)18F24B0069, (01)10801902172904(17)260228(10)18F24B0067, (01)10801902172904(17)260228(10)18F24B0070, (01)10801902172904(17)260228(10)18F24B0071, (01)10801902172904(17)260228(10)18F24C0006, (01)10801902172904(17)260228(10)18F24C0007, (01)10801902172904(17)260228(10)18F24C0028, (01)10801902172904(17)260228(10)18F24C0029, (01)10801902172904(17)260228(10)18F24C0030, (01)10801902172904(17)260228(10)18F24C0038, (01)10801902172904(17)260228(10)18F24C0092, (01)10801902172904(17)260228(10)18F24C0120, (01)10801902172904(17)260228(10)18F24C0121, (01)10801902172904(17)260228(10)18F24C0141; c) REF IAB-06850-U, UDI: (01)10801902144192(17)240831(10)18F22J0020(13)220916, (01)10801902144192(17)240831(10)18F22J0038(13)220928, (01)10801902144192(17)240831(10)18F22J0043(13)220930, (01)10801902144192(17)240930(10)18F22K0001(13)221003, (01)10801902144192(17)240930(10)18F22K0003(13)221004, (01)10801902144192(17)240930(10)18F22K0006(13)221006, (01)10801902144192(17)240930(10)18F22K0011(13)221007, (01)10801902144192(17)240930(10)18F22K0012(13)221007, (01)10801902144192(17)240930(10)18F22K0013(13)221007, (01)10801902144192(17)241231(10)18F23A0075(13)230131, (01)10801902144192(17)250131(10)18F23B0005(13)230203, (01)10801902144192(17)250131(10)18F23B0010(13)230206, (01)10801902144192(17)250131(10)18F23B0029(13)230220, (01)10801902144192(17)250131(10)18F23B0030(13)230220, (01)10801902144192(17)250228(10)18F23C0007(13)230307, (01)10801902144192(17)250228(10)18F23C0008(13)230307, (01)10801902144192(17)250228(10)18F23C0014(13)230310, (01)10801902144192(17)250228(10)18F23C0015(13)230310, (01)10801902144192(17)250531(10)18F23F0016(13)230609, (01)10801902144192(17)250531(10)18F23F0017(13)230609, (01)10801902144192(17)250831(10)18F23J0043(13)230921, (01)10801902144192(17)250831(10)18F23J0044(13)230923, (01)10801902144192(17)250930(10)18F23J0078(13)231031, (01)10801902144192(17)250930(10)18F23K0015(13)231031, (01)10801902144192(17)250930(10)18F23K0024(13)231014, (01)10801902144192(17)251031(10)18F23L0045(13)231130, (01)10801902144192(17)251130(10)18F23L0052(13)231205, (01)10801902144192(17)251130(10)18F23L0058(13)231205, (01)10801902144192(17)260131(10)18F24B0011(13)240209, (01)10801902144192(17)260131(10)18F24B0012(13)240209, (01)10801902172911(17)250831(10)18F23H0061(13)230911, (01)10801902172911(17)260131(10)18F24B0010(13)240207

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1879-2024

Related Recalls

Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS; (5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID; (6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC; (7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA; (8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD; (9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL; (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-MHS; (11) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, 018 inch dia. spring-wire guide, REF ASK-04020-MIB3; (12) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring- wire guide, REF ASK-04020-PRH; (13) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 dia. spring-wire guide, REF ASK-04020-UOIL; (14) Arrow QuickFlash Radial Artery Catheterization Kit, 20 Ga., 3.81 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04220-KSP; and (15) Arrow Arterial Catheterization Kit, 20 Ga. 4.45/12 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04500-HFH4.

ARROW INTERNATIONAL

Class I - Dangerous

Reports have been received regarding open seals on the packaging.

Jul 26, 2024 Surgical Instruments Nationwide View Details →

Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

ARROW INTERNATIONAL

Class I - Dangerous

Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

Apr 29, 2024 Surgical Instruments Nationwide View Details →

Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U

ARROW INTERNATIONAL

Class I - Dangerous

Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

Apr 29, 2024 Surgical Instruments Nationwide View Details →