Drug product
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 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: 32-005585
D-0159-2018
Product summary
- Event
- Event 78369
- Status
- Terminated
- Classification
- Class II
- Quantity
- 130,740 16 oz bottles
- Official record key
drug-enforcement:D-0159-2018
Official wording
Reason: Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Code information: Lot: A259, A260, EXP 05-26-2018; A301, 06-23-2018; B117, B118, EXP 03-02-2019; C005, EXP 01-09-2020; C219, EXP 05-24-2020; Z521, EXP 10-06-2017
Distribution pattern: IA, WI
Derived failure modes
-
Sterility assurance
Lack of sterility