Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center; (5) 89-10526.04, CNRV LAPAROSCOPY PACK, New River Valley Medical Center; (6) 89-10530.04, CNRV PERIPHERAL VAS PACK, New River Valley Medical Center; (7) 89-10532.04, CNRV SPINE PACK, New River Valley Medical Center; (8) 89-10534.02, CMC ANTERIOR SPINE PACK, Carilion Roanoke Memorial Hosp; (9) 89-10544.03, CORONARY BYPASS PACK PGYBK, Carilion Roanoke Memorial Hosp; (10) 89-10545.02, CMC CRANIOTOMY PACK, Carilion Roanoke Memorial Hospital; (11) 89-10552.02, CMC EXTREMITY PACK, Carilion Roanoke Memorial Hospital; (12) 89-10553.02, CMC GYN LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital; (13) 89-10554.02, CMC GYN MAJOR PACK, Carilion Roanoke Memorial Hospital; (14) 89-10555.02, ORTHO MAJOR PACK, Carilion Roanoke Memorial Hospital; (15) 89-10556.02, CMC HYSTEROSCOPY PACK, Carilion Roanoke Memorial Hospital; (16) 89-10558.04, CCASC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital; (17) 89-10560.03, CMC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital; (18) 89-10561.02, CMC LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital; (19) 89-10562.02, CMC MINOR ENT/PLASTIC PACK, Carilion Roanoke Memorial Hospital; (20) 89-10564.02, CMC MAJOR PLASTIC PACK, Carilion Roanoke Memorial Hospital; (21) 89-10569.02, CMC PEDIATRIC PACK, Carilion Roanoke Memorial Hospital; (22) 89-10570.02, CMC POSTERIOR SPINE PACK, Carilion Roanoke Memorial Hospital; (23) 89-10574.02, CMC SHOULDER ARTHROSCOPY PACK, Carilion Roanoke Memorial Hospital; (24) 89-10575.02, OWEN HIP PACK, Carilion Roanoke Memorial Hosp; (25) 89-10576.03, THORACOSCOPY / THORACOTOMY, Carilion Roanoke Memorial Hosp; (26) 89-10580.03, VALVE REPLACEMENT PACK PGYBK, Carilion Roanoke Memorial Hosp.

Class I - Dangerous

🏥 Medical Devices Recalled: April 17, 2023 DeRoyal Industries Implants & Prosthetics Nationwide

What Should You Do?

Check if you have this product:
(1) 89-10507.02 - lot 58700464, exp 12/1/2024, GTIN pack-00749756362788, case-50749756362783; (2) 89-10508.02 - lot 58700430, exp 9/1/2026, GTIN pack-00749756362818, case-50749756362813; (3) 89-10509.02 - lot 58775010, exp 12/1/2024, GTIN pack-00749756362832, case-50749756362837; (4) 89-10517.04 - lot 58700579, exp 12/1/2024, GTIN pack-00749756363228, case-50749756363223; (5) 89-10526.04 - lot 58388765, exp 11/1/2024, GTIN pack-00749756363242, case-50749756363247; (6) 89-10530.04 - lot 58543121, exp 11/1/2024, GTIN pack-00749756364447, case-50749756364442; (7) 89-10532.04 - lot 58543905, exp 7/1/2024, GTIN pack-00749756363266, case-50749756363261; (8) 89-10534.02 - lots 58565821 and 58700561, exp 3/1/2024, GTIN pack-00749756363532, case-50749756363537; (9) 89-10544.03 - lot 58700000, exp 10/1/2024, GTIN pack-00749756366342, case-50749756366347; (10) 89-10545.02 - lot 58565830, exp 3/1/2024, GTIN pack-00749756363556, case-50749756363551; (11) 89-10552.02 - lot 58700667, 58700675, and 58724108, exp 12/1/2024, GTIN pack-00749756363549, case-50749756363544; (12) 89-10553.02 - lot 58544060, exp 11/1/2024, GTIN pack-00749756363624, case-50749756363629; (13) 89-10554.02 - lot 58544166, exp 12/1/2024, GTIN pack-00749756363440, case-50749756363445; (14) 89-10555.02 - lot 58589647 and 58724116, exp 12/1/2024, GTIN pack-00749756363648, case-50749756363643; (15) 89-10556.02 - lot 58589567, exp 12/1/2024, GTIN pack-00749756364287, case-50749756364282; (16) 89-10558.04 - lot 58542769, exp 11/1/2024, lot 58621694 and 58699993, exp 12/1/2024, GTIN pack-00749756364430, case-50749756364435; (17) 89-10560.03 - lot 58543201, 58554436, and 58700499, exp 9/1/2024, GTIN pack-00749756363778, case-50749756363773; (18) 89-10561.02 - lot 58542793, exp 11/1/2024, lot 58589591 and 58738016, exp 12/1/2024, GTIN pack-00749756363723, case-50749756363728; (19) 89-10562.02 - lot 58621820, exp 10/1/2024, GTIN pack-00749756364140, case-50749756364145; (20) 89-10564.02 - lot 58543083, exp 11/1/2024, and lot 58700501, exp 12/1/2024, GTIN pack-00749756363761, case-50749756363766; (21) 89-10569.02 - lot 58544182 exp 12/1/2024, GTIN pack-00749756363457, case-50749756363452; (22) 89-10570.02 - lot 58700739, exp 1/1/2024, and 58775036, exp 3/14/2024, GTIN pack-00749756363587, case-50749756363582; (23) 89-10574.02 - lot 58700641, exp 7/1/2024, GTIN pack-00749756364041, case-50749756364046; (24) 89-10575.02 - lot 58565848, exp 12/1/2023, GTIN pack-00749756366144, case-50749756366149; (25) 89-10576.03 - lot 58700704, exp 12/1/2024, GTIN pack-00749756364126, case-50749756364121; (26) 89-10580.03 - lot 58543454, exp 8/1/2024, GTIN pack-00749756366328, case-50749756366323.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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:: DeRoyal Industries Inc
Reason for Recall:: The custom procedure packs contain light handle covers that have been recalled by another firm.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Sterile custom surgical procedure packs: (1) 89-10507.02, TOTAL KNEE PACK, Stonewall Jackson Hospital; (2) 89-10508.02, LOCAL PACK, Stonewall Jackson Hospital; (3) 89-10509.02, LAPAROTOMY PACK, Stonewall Jackson Hospital; (4) 89-10517.04, CNRV BASIC SETUP PACK, New River Valley Medical Center; (5) 89-10526.04, CNRV LAPAROSCOPY PACK, New River Valley Medical Center; (6) 89-10530.04, CNRV PERIPHERAL VAS PACK, New River Valley Medical Center; (7) 89-10532.04, CNRV SPINE PACK, New River Valley Medical Center; (8) 89-10534.02, CMC ANTERIOR SPINE PACK, Carilion Roanoke Memorial Hosp; (9) 89-10544.03, CORONARY BYPASS PACK PGYBK, Carilion Roanoke Memorial Hosp; (10) 89-10545.02, CMC CRANIOTOMY PACK, Carilion Roanoke Memorial Hospital; (11) 89-10552.02, CMC EXTREMITY PACK, Carilion Roanoke Memorial Hospital; (12) 89-10553.02, CMC GYN LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital; (13) 89-10554.02, CMC GYN MAJOR PACK, Carilion Roanoke Memorial Hospital; (14) 89-10555.02, ORTHO MAJOR PACK, Carilion Roanoke Memorial Hospital; (15) 89-10556.02, CMC HYSTEROSCOPY PACK, Carilion Roanoke Memorial Hospital; (16) 89-10558.04, CCASC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital; (17) 89-10560.03, CMC LAPAROTOMY PACK, Carilion Roanoke Memorial Hospital; (18) 89-10561.02, CMC LAPAROSCOPY PACK, Carilion Roanoke Memorial Hospital; (19) 89-10562.02, CMC MINOR ENT/PLASTIC PACK, Carilion Roanoke Memorial Hospital; (20) 89-10564.02, CMC MAJOR PLASTIC PACK, Carilion Roanoke Memorial Hospital; (21) 89-10569.02, CMC PEDIATRIC PACK, Carilion Roanoke Memorial Hospital; (22) 89-10570.02, CMC POSTERIOR SPINE PACK, Carilion Roanoke Memorial Hospital; (23) 89-10574.02, CMC SHOULDER ARTHROSCOPY PACK, Carilion Roanoke Memorial Hospital; (24) 89-10575.02, OWEN HIP PACK, Carilion Roanoke Memorial Hosp; (25) 89-10576.03, THORACOSCOPY / THORACOTOMY, Carilion Roanoke Memorial Hosp; (26) 89-10580.03, VALVE REPLACEMENT PACK PGYBK, Carilion Roanoke Memorial Hosp.

Product Codes/Lot Numbers:

(1) 89-10507.02 - lot 58700464, exp 12/1/2024, GTIN pack-00749756362788, case-50749756362783; (2) 89-10508.02 - lot 58700430, exp 9/1/2026, GTIN pack-00749756362818, case-50749756362813; (3) 89-10509.02 - lot 58775010, exp 12/1/2024, GTIN pack-00749756362832, case-50749756362837; (4) 89-10517.04 - lot 58700579, exp 12/1/2024, GTIN pack-00749756363228, case-50749756363223; (5) 89-10526.04 - lot 58388765, exp 11/1/2024, GTIN pack-00749756363242, case-50749756363247; (6) 89-10530.04 - lot 58543121, exp 11/1/2024, GTIN pack-00749756364447, case-50749756364442; (7) 89-10532.04 - lot 58543905, exp 7/1/2024, GTIN pack-00749756363266, case-50749756363261; (8) 89-10534.02 - lots 58565821 and 58700561, exp 3/1/2024, GTIN pack-00749756363532, case-50749756363537; (9) 89-10544.03 - lot 58700000, exp 10/1/2024, GTIN pack-00749756366342, case-50749756366347; (10) 89-10545.02 - lot 58565830, exp 3/1/2024, GTIN pack-00749756363556, case-50749756363551; (11) 89-10552.02 - lot 58700667, 58700675, and 58724108, exp 12/1/2024, GTIN pack-00749756363549, case-50749756363544; (12) 89-10553.02 - lot 58544060, exp 11/1/2024, GTIN pack-00749756363624, case-50749756363629; (13) 89-10554.02 - lot 58544166, exp 12/1/2024, GTIN pack-00749756363440, case-50749756363445; (14) 89-10555.02 - lot 58589647 and 58724116, exp 12/1/2024, GTIN pack-00749756363648, case-50749756363643; (15) 89-10556.02 - lot 58589567, exp 12/1/2024, GTIN pack-00749756364287, case-50749756364282; (16) 89-10558.04 - lot 58542769, exp 11/1/2024, lot 58621694 and 58699993, exp 12/1/2024, GTIN pack-00749756364430, case-50749756364435; (17) 89-10560.03 - lot 58543201, 58554436, and 58700499, exp 9/1/2024, GTIN pack-00749756363778, case-50749756363773; (18) 89-10561.02 - lot 58542793, exp 11/1/2024, lot 58589591 and 58738016, exp 12/1/2024, GTIN pack-00749756363723, case-50749756363728; (19) 89-10562.02 - lot 58621820, exp 10/1/2024, GTIN pack-00749756364140, case-50749756364145; (20) 89-10564.02 - lot 58543083, exp 11/1/2024, and lot 58700501, exp 12/1/2024, GTIN pack-00749756363761, case-50749756363766; (21) 89-10569.02 - lot 58544182 exp 12/1/2024, GTIN pack-00749756363457, case-50749756363452; (22) 89-10570.02 - lot 58700739, exp 1/1/2024, and 58775036, exp 3/14/2024, GTIN pack-00749756363587, case-50749756363582; (23) 89-10574.02 - lot 58700641, exp 7/1/2024, GTIN pack-00749756364041, case-50749756364046; (24) 89-10575.02 - lot 58565848, exp 12/1/2023, GTIN pack-00749756366144, case-50749756366149; (25) 89-10576.03 - lot 58700704, exp 12/1/2024, GTIN pack-00749756364126, case-50749756364121; (26) 89-10580.03 - lot 58543454, exp 8/1/2024, GTIN pack-00749756366328, case-50749756366323.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1691-2023

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