Recall Z-0845-2024 ยท GAP Suture, Nonabsorbable, Silk
Covidien LP
Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36 S-246 SOFSILK* 0 BLK 6X60CM PCT X36 S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA S-303 SOFSILK* 4-0 BLK 12X
| Date | Jan 29, 2024 (initiated Dec 21, 2023) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 organizat |
| Quantity | 46,812 US; 68,976 OUS |
| Distribution | Worldwide US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, HI, IA, IL, IN, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, PR, TN, TX, VA, WA, WV and the countries of Australia, Bahrain, Belgium, Bulgaria, Canary Islands, China, Cyprus, Czech Republic, Finland, Fra |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981128 | SOFSILK SUTURE United States Surgical, A Division of Tyco Healthc, May 11, 1998 |