Device product
Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
Z-0691-2017
Product summary
- Event
- Event 75291
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15,950 units
- Official record key
device-enforcement:Z-0691-2017
Official wording
Reason: Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.
Code information: Lot Number 361105, exp date 1/01/2017, Product Catalog Number 375198
Distribution pattern: Nationwide Distribution to GA, IL, and FL
Derived failure modes
-
Unknown
Positive results from non-routine sterility testing commissioned by B. Braun Medical Inc. (BBMI) for the finished product of this lot.