FDA Drug recall D-0159-2018
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box
- FDA Drug
- Class II
- terminated
- Published 2018-01-17
On 2018-01-17 the FDA classified a Class II recall of Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box by Medex Cardio Pulmonary D B A Smiths Medical, citing lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0159-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-05 |
| Published | 2018-01-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Medex Cardio Pulmonary D B A Smiths Medical |
| Distribution | IA, WI |
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
Reason
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0159-2018%22
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