FDA Device recall Z-0945-2023
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits 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 Fluid Filter Transfer Kit, Sterile, 60 kits 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-0945-2023 |
| 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 Fluid Filter Transfer Kit, Sterile, 60 kits 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.FFTK, UDI-DI: M752TMFFTK0, Lot Numbers: 220954416, 222418904, 221056552, 220070456, 220400116, 22041…Assembly Number TM.FFTK, UDI-DI: M752TMFFTK0, Lot Numbers: 220954416, 222418904, 221056552, 220070456, 220400116, 220411513, 220952568, 220943346, 221727862, 222709611, 222701385 |
|---|
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-0945-2023%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.