Device product
AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Z-0069-2018
Product summary
- Event
- Event 78366
- Status
- Terminated
- Classification
- Class II
- Quantity
- 60 kits
- Official record key
device-enforcement:Z-0069-2018
Official wording
Reason: Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.
Code information: Lot # 109138
Distribution pattern: US Distribution to the state of : SC
Derived failure modes
-
Sterility assurance
sterile barrier breach