Sterile Eyewash — Class II drug recall D-0158-2018
Terminated recall by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, reported 2018-01-17, distributed in IA, WI. Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
| Recall number | D-0158-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, Vernon Hills, IL, United States |
| Recall initiated | 2017-09-05 |
| Classified | 2018-01-05 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2018-12-19 |
| Distributed | IA, WI |
| Quantity | 22,080 |
| Reason classes | sterility, packaging |
| Lot numbers | A225 |
| Model numbers | 32-005583 |
Product
Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 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: 32-005583
Reason for recall
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0158-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.