Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿ — Class I medical device recall Z-0718-2019
Terminated recall by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, reported 2019-02-13, distributed nationwide. Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
| Recall number | Z-0718-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| 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 | 2019-02-04 |
| Reported by FDA | 2019-02-13 |
| Terminated | 2024-04-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CH, CL, CY, CZ, DE, EC, EE, GR, IT, JP |
| Quantity | 235,560 |
| Reason classes | sterility, packaging |
| Lot numbers | A056, A057, A058, A103, A176, A455, B530, B531, B532, B533, Z101, Z534, Z553, Z554 |
| Model numbers | HCS00350 |
Product
Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿
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/Z-0718-2019. 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.