FDA Device recall Z-2300-2021
NEO DELTA Self Safe 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
- 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 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units 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-2300-2021 |
| 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 1, I.V. Catheter with PUR REF 3708122, Lot 00A1160627 5000 units
Reason
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Identifiers
| code_info | REF 3708122, Lot 00A1160627 |
|---|
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-2300-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.