Device product
Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.
Z-1950-2014
Product summary
- Event
- Event 68564
- Status
- Terminated
- Classification
- Class II
- Quantity
- 474 cs (9,480 ea) total for all kits involved.
- Official record key
device-enforcement:Z-1950-2014
Official wording
Reason: Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
Code information: Model number: 68350, Lot numbers: 187146, 187341, 187150 & 187148, Exp. Date: 12/01/2016; Model number: 58168, Lot number: 187212, Exp. Date: 11/1/2016; Model number: 68297B, Lot number: 187196, Exp. Date: 12/1/2016 and Model number: 72851B, Lot number: 187208, Exp. Date: 12/1/2018.
Distribution pattern: Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.
Derived failure modes
-
Sterility assurance
sterile kits may have incomplete seals which might compromise