Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 B…

Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT

Model 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT UDI-DI 10884521071728, 20884521071725 Lots D1L1929RY D2B2243RY Model 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT UDI-DI 10884521071742, 20884521071749 Lot D2B0176RY Model 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT UDI-DI 10884521071766 Lots D2D2437RY UDI-DI 20884521071763 Lots D2D2437RY D2E0905RY D2E0916RY Model 88861919-71 SURGILON* 1 BLK 7X75CM PCT UDI-DI 20884521071794 Lots D1M0640RY D1M1494RY

Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.

On December 21, the firm notified affected consignees via URGENT MEDICAL DEVICE RECALL letters. Customers were instructed to identify, quarantine, and return all unused, non-expired affected sutures to Medtronic. Please contact rs.covidienfeedbackcustomerservice@medtronic.com for the Return Good Authorization (RGA). Customers will receive credit for returned affected product. If purchased from a distributor, please contact your distributor directly to arrange for the return of product back to your distributor. Pass on the recall notice to all those who need to be aware within your organization, or to any organization where the affected sutures have been transferred or distributed. If you have questions regarding this recall, please call Medtronic Quality Assurance at 800-255-6774 option 1, then option 1 ***Updated 4/1/2024*** Firm identified additional models and lots affected by the gamma radiation issue and sent additional notification to customers on January 25, 2024.

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