🔍 RecallPedia

Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

Class I - Dangerous
🏥 Medical Devices Recalled: January 11, 2022 TELEFLEX MEDICAL Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Number / UDI: 13F19K0564 / (01)20801902156758 (17)210930 (10)13F19K0564, Components: Code PT-12709-CA, Lot number 13C19K2024; Code PT-65709-HS, Lot number 14C19K1035; Code PT-03009, Lot number 13C19J1873; Lot Number / UDI: 13F20C0094 / (01)10801902121254 (17)220228 (10)13F20C0094, Components: Code PT-12709-C, Lot number 13C20C0498; Code PT-65709-HS, Lot number 14C19K1035; Code PT-03009, Lot number 13C19L0622; Code PT-03009, Lot number 13C19M0278; Code PT-03009, Lot number 13C19J1873; Lot Number / UDI: 13F20G0284 / (01)10801902121254 (17)220630 (10)13F20G0284, Components: Code PT-12709-C, Lot number 13C20G0230; Code PT-65709-HS, Lot number 14C20D1061; Code PT-03009, Lot number 13C20G0238; Code PT-03009, Lot number 13C20F2585; Lot Number / UDI: 13F20L0282 / (01)10801902121254 (17)221031 (10)13F20L0282, Components: Code PT-12709-C, Lot number 13C20J0307; Code PT-65709-HS, Lot number 14C20H0384; Code PT-03009, Lot number 13C20L0872; Lot Number / UDI 13F21A0497 / (01)10801902121254 (17)221231 (10)13F21A0497, Components: Code PT-12709-C, Lot number 13C20J0307; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C20M0144; Lot Number / UDI: 13F21A0718 / (01)10801902121254 (17)230131 (10)13F21A0718, Components: Code PT-12709-C, Lot number 13C21A1963; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C21A0855; Code PT-03009, Lot number 13C20M0144; Lot Number / UDI: 13X21E0008 / (01)10801902121254 (17)230630 (10)13F21F1187, Components: Code PT-12709-C, Lot number 13C21C1690; Code PT-65709-HS, Lot number 14C21D0635; Code PT-65709-HS, Lot number 14C21C0476; Code PT-03009, Lot number 13C21C2413; Lot Number / UDI: 13F21F1187 / (01)10801902121254 (17)230531 (10)13X21E0008, Components: Code PT-12709-C, Lot number 13X21E0009; Code PT-65709-HS, Lot number 14X21D0002; Code PT-03009, Lot number 13X21E0007
  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:
TELEFLEX MEDICAL INC
Reason for Recall:
The firm received reports indicating PTD tip separation during use.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

Product Codes/Lot Numbers:

Lot Number / UDI: 13F19K0564 / (01)20801902156758 (17)210930 (10)13F19K0564, Components: Code PT-12709-CA, Lot number 13C19K2024; Code PT-65709-HS, Lot number 14C19K1035; Code PT-03009, Lot number 13C19J1873; Lot Number / UDI: 13F20C0094 / (01)10801902121254 (17)220228 (10)13F20C0094, Components: Code PT-12709-C, Lot number 13C20C0498; Code PT-65709-HS, Lot number 14C19K1035; Code PT-03009, Lot number 13C19L0622; Code PT-03009, Lot number 13C19M0278; Code PT-03009, Lot number 13C19J1873; Lot Number / UDI: 13F20G0284 / (01)10801902121254 (17)220630 (10)13F20G0284, Components: Code PT-12709-C, Lot number 13C20G0230; Code PT-65709-HS, Lot number 14C20D1061; Code PT-03009, Lot number 13C20G0238; Code PT-03009, Lot number 13C20F2585; Lot Number / UDI: 13F20L0282 / (01)10801902121254 (17)221031 (10)13F20L0282, Components: Code PT-12709-C, Lot number 13C20J0307; Code PT-65709-HS, Lot number 14C20H0384; Code PT-03009, Lot number 13C20L0872; Lot Number / UDI 13F21A0497 / (01)10801902121254 (17)221231 (10)13F21A0497, Components: Code PT-12709-C, Lot number 13C20J0307; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C20M0144; Lot Number / UDI: 13F21A0718 / (01)10801902121254 (17)230131 (10)13F21A0718, Components: Code PT-12709-C, Lot number 13C21A1963; Code PT-65709-HS, Lot number 14C20J1453; Code PT-03009, Lot number 13C21A0855; Code PT-03009, Lot number 13C20M0144; Lot Number / UDI: 13X21E0008 / (01)10801902121254 (17)230630 (10)13F21F1187, Components: Code PT-12709-C, Lot number 13C21C1690; Code PT-65709-HS, Lot number 14C21D0635; Code PT-65709-HS, Lot number 14C21C0476; Code PT-03009, Lot number 13C21C2413; Lot Number / UDI: 13F21F1187 / (01)10801902121254 (17)230531 (10)13X21E0008, Components: Code PT-12709-C, Lot number 13X21E0009; Code PT-65709-HS, Lot number 14X21D0002; Code PT-03009, Lot number 13X21E0007

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0623-2022

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TELEFLEX MEDICAL

Class I - Dangerous

Reports received of torn corrugated breathing tubes.

Apr 11, 2022 Infusion Pumps Nationwide View Details →

Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.

TELEFLEX MEDICAL

Class I - Dangerous

The firm received reports indicating PTD tip separation during use.

Jan 11, 2022 Surgical Instruments Nationwide View Details →