FDA Device recall Z-2295-2021
DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
- FDA Device
- Class II
- ongoing
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272 by Delta Med Spa, citing problems related to the sterilization of the medical devices; possible missing sterility of the medical device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2295-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-06-21 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Delta Med Spa |
| Distribution | US |
Product
DELTAVEN Safety I.V. Catheter in Pur with closed system: a) REF 3836272 b) REF 3814272 c) REF 3845272 d) REF 3856272
Reason
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Identifiers
| code_info | a) REF 3836272, Lot 11T80188 b) REF 3814272, Lot 11T80272 c) REF 3845272, Lot 12T80147 d) REF 3856272, Lot 12T80347 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2295-2021%22
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