FDA Drug recall D-0160-2018
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 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), 32 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-0160-2018 |
| 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), 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
Reason
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Identifiers
| code_info | 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…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. |
|---|
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-0160-2018%22
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