Drug product
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061 Model Number: 32-005582.
D-0157-2018
Product summary
- Event
- Event 78369
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29,232 1 oz bottle
- Official record key
drug-enforcement:D-0157-2018
Official wording
Reason: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Code information: Lot: Z516
Distribution pattern: IA, WI
Derived failure modes
-
Sterility assurance
Lack of sterility