WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF… — Class II medical device recall Z-2305-2021
Ongoing recall by Delta Med SpA, reported 2021-08-25, distributed nationwide. Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
| Recall number | Z-2305-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Delta Med SpA, Viadana, N/A, Italy |
| Recall initiated | 2021-06-21 |
| Classified | 2021-08-16 |
| Reported by FDA | 2021-08-25 |
| Distributed | Nationwide (US) |
| Quantity | 40,000 units |
| Reason classes | sterility |
| Lot numbers | 1100256, 1100316, 1200084 |
| Model numbers | PIV2210W, PIV2475W, PIVD2010W |
Product
WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
Reason for recall
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
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-2305-2021. 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.