NEO DELTA Self Safe T — Class II medical device recall Z-2301-2021
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-2301-2021 |
|---|---|
| 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 | 20,000 units |
| Reason classes | sterility |
| Lot numbers | 00A1160635, 00A1160638, 00A1160656 |
| Model numbers | 3708522, 3769522, 3779422 |
Product
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
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-2301-2021. 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.