Drug product
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 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: 32-005587
D-0160-2018
Product summary
- Event
- Event 78369
- Status
- Terminated
- Classification
- Class II
- Quantity
- 96,828 32 oz bottles
- Official record key
drug-enforcement:D-0160-2018
Official wording
Reason: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Code information: Lot: A257, EXP 05-20-2018; A258, EXP 05-19-2018; B017, EXP 01-12-2019; B116, B119, EXP 05-03-2019; B120, EXP 05-04-2019; B131, EXP 05-05-2019; Z535, EXP 10-13-2017; Z638, EXP 12-19-2017.
Distribution pattern: IA, WI
Derived failure modes
-
Sterility assurance
Lack of sterility