DELTAVEN Y DNL Safety I — Class II medical device recall Z-2296-2021
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-2296-2021 |
|---|---|
| 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 | 203,680 units |
| Reason classes | sterility |
| Lot numbers | 11T80149, 11T80189, 11T80198, 11T80292, 12T80230, 12T80302, 12T80349 |
| Model numbers | 3810572, 3821572, 3831572, 3832572, 3833572, 3842572, 3852572 |
Product
DELTAVEN Y DNL Safety I.V. Catheter in Pur with closed system: a) REF 3832572 b) REF 3842572 c) REF 3821572 d) REF 3833572 e) REF 3831572 f) REF 3810572 g) REF 3852572
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-2296-2021. 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.