Device product
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
Z-0844-2024
Product summary
- Firm
- Covidien LP
- Event
- Event 93768
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 46,812 US; 68,976 OUS
- Official record key
device-enforcement:Z-0844-2024
Official wording
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.
Code information: 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
Distribution pattern: 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, Netherlands, New Zealand, Panama, Poland, Portugal, Puerto Rico, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom.
Derived failure modes
-
Unknown
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.