Flexima APDL Drainage Catheter System and Kit — Class II medical device recall Z-3147-2024
Ongoing recall by Boston Scientific Corporation, reported 2024-09-25. There is the potential for holes in the clear sterile barrier of the device pouch which may impact device ster
| Recall number | Z-3147-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2024-07-18 |
| Classified | 2024-09-13 |
| Reported by FDA | 2024-09-25 |
| Countries outside the US | CO, PH, RU |
| Quantity | 89 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00871472932348 |
| Lot numbers | 33471466, 33540319 |
| Model numbers | M001271960, M001271970 |
| Expiration dates | 2027-02-21, 2027-03-01 |
Product
Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail
Reason for recall
There is the potential for holes in the clear sterile barrier of the device pouch which may impact device 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-3147-2024. 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.