Prodimed Combicath Paediatric catheters for blind protected distal… — Class II medical device recall Z-2491-2020
Terminated recall by Prodimed Plastimed Division, reported 2020-07-15, distributed nationwide. Lack of assurance of sterility
| Recall number | Z-2491-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Prodimed Plastimed Division, Le Plessis Bouchard, France |
| Recall initiated | 2020-05-27 |
| Classified | 2020-07-04 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2021-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 180 |
| Reason classes | sterility |
Product
Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling- COMBICATH 35 cm x 1.9 mm Product Code: 58 223 19US
Reason for recall
Lack of assurance of sterility
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-2491-2020. 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.