Drug product
Aid Backpack Kit - Product Code 85-0917, North American Rescue
D-0182-2017
Product summary
- Event
- Event 75415
- Status
- Terminated
- Classification
- Class II
- Quantity
- unknown
- Official record key
drug-enforcement:D-0182-2017
Official wording
Reason: Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Code information: Kit Part # 85-0917 - Kit Lot # 85-0917041916
Distribution pattern: Nationwide, Australia & Switzerland
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility