FDA Device recall Z-0946-2023
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case
- FDA Device
- Class II
- ongoing
- Published 2023-01-18
On 2023-01-18 the FDA classified a Class II recall of Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case by Stradis Healthcare, citing potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0946-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-15 |
| Published | 2023-01-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stradis Healthcare |
| Distribution | US |
Product
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Reason
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Identifiers
| code_info | Assembly Number TM.SCP1ML, UDI-DI: M752TMSCP1ML0, Lot Numbers: 222270319, 220834335 |
|---|
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-0946-2023%22
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