DELTAVEN FASTFLASH — Class II medical device recall Z-2297-2021
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-2297-2021 |
|---|---|
| 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 | 229,320 units |
| Reason classes | sterility |
| Lot numbers | 11T00118, 11T00119, 11T00120, 11T00121, 11T00122, 11T00142, 11T00143, 11T00146, 11T00147, 11T00148, 11T00177, 11T00178, 11T00179, 11T00230, 11T00231, 11T00232, 11T05089, 11T05136, 11T05166, 11T10007, 11T10015, 11T10016, 12T00180, T1010018 |
| Model numbers | 3800473, 3800573, 3804773, 3811473, 3814773, 3821473, 3821573, 3824773, 3825773, 3831473, 3831573, 3832473, 3832573, 3833473, 3833573, 3835773, 3836773, 3837773, 3842473, 3842573, 3843473, 3845773, 3846773, 3847773 |
Product
DELTAVEN FASTFLASH, Safety I.V. Catheter in Pur with closed system: a) REF 3814773 b) REF 3835773 c) REF 3825773 d) REF 3837773 e) REF 3846773 f) REF 3831473 g) REF 3842473 h) REF 3821473 i) REF 3832473 j) REF 3833473 k) REF 3821573 l) REF 3831573 m) REF 3833573 n) REF 3824773 o) REF 3804773 p) REF 3845773 q) REF 3811473 r) REF 3836773 s) REF 3843473 t) REF 3800473 v) REF 3842573 w) REF 3832573 x) REF 3847773 y) REF 3800573
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-2297-2021. 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.