FDA Device recall Z-2301-2021
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
- FDA Device
- Class II
- ongoing
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522 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-2301-2021 |
| 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
NEO DELTA Self Safe T, I.V. catheter of PUR a) REF 3779422 b) REF 3769522 c) REF 3708522
Reason
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Identifiers
| code_info | a) REF 3779422, Lot 00A1160635 b) REF 3769522, Lot 00A1160656 c) REF 3708522, Lot 00A1160638 |
|---|
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-2301-2021%22
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