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

Hazard

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.

Details from the source

Reason for recall: 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. 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, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic Of Kosovo, Mongolia, Netherlan Quantity: 46,812 US; 68,976 OUS Lot/code info: Model CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 UDI-DI 20884521083629 Lot D1L1576RY Model GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 UDI-DI 20884521085203 Lot D2B1216RY Model S-176 SOFSILK* 0 BLK 12X45CM PCT X24 UDI-DI 20884521085746 Lot D2D0612RY Model S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 UDI-DI 20884521085944 Lot D2B0728RY Model S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 UDI-DI 20884521085968 Lots D2D0972RY D2E2396RY Model S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 UDI-DI 20884521085975 Lots D2D0957RY D2D0968RY D2D0971RY D2D0984RY D2D0985RY D2E0900RY D2E0902RY Model S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36 UDI-DI 10884521086197 Lot D2E0674RY UDI-DI 20884521086194 Lots D2D1871RY D2E0674RY D2E0901RY Model S-246 SOFSILK* 0 BLK 6X60CM PCT X36 UDI-DI 20884521086200 Lot D2D0980RY Model S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA UDI-DI 20884521086422 Lot D2F2101RY Model S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36 UDI-DI 20884521086460 Lots D2D1872RY D2D2120RY Model S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36 UDI-DI 20884521086477 Lot D2D1991RY Model S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36 UDI-DI 20884521086484 Lots D2E0907RY D2E2685RY Model S-316 SOFSILK* 0 BLK 12X75CM PCT X24 UDI-DI 20884521086491 Lot D2D2436RY Model S-317 SOFSILK* 1 BLK 12X75CM PCT X24 UDI-DI 20884521086514 Lot D2E0587RY Model S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36 UDI-DI 20884521086620 Lot D2E0676RY Model S-606 SOFSILK* 0 BLK 2X150CM PCT X36 UDI-DI 10884521086630 Lot D2B2638RY UDI-DI 20884521086637 Lots D2B2638RY D2D0961RY Model S606-12 SOFSIL

UPC codes

20884521083629, 20884521085203, 20884521085746, 20884521085944, 20884521085968, 20884521085975, 10884521086197, 20884521086194, 20884521086200, 20884521086422, 20884521086460, 20884521086477, 20884521086484, 20884521086491, 20884521086514, 20884521086620, 10884521086630, 20884521086637, 10884521637887, 20884521086675, 20884521758121, 20884521757971, 20884521084756, 20884521085470, 20884521085630, 20884521085739, 20884521085784, 20884521085876, 20884521085982, 20884521086170, 10884521086203, 20884521086408, 20884521086453, 20884521086538, 20884521176406, 20884521086668, 20884521090184, 20884521758060, 20884521086774, 20884521086804

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.