FDA Device recall Z-2305-2021
WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
- FDA Device
- Class II
- ongoing
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W 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-2305-2021 |
| 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
WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W
Reason
Problems related to the sterilization of the medical devices; possible missing sterility of the medical device
Identifiers
| code_info | a) REF PIVD2010W, Lot 1100256 b) REF PIV2210W, Lot 1100316 c) REF PIV2475W, Lot 1200084 |
|---|
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-2305-2021%22
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