Z-0945-2023 Class II Ongoing
FDA device recall Z-0945-2023 was initiated by Stradis Healthcare on December 15, 2022 and is designated Class II. Reason for recall: Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. The recall status is ongoing. Affected quantity: 1,175 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 18, 2023
- Initiation Date
- December 15, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,175 units
Product Description
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Reason for Recall
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Distribution Pattern
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Code Information
Assembly Number TM.FFTK, UDI-DI: M752TMFFTK0, Lot Numbers: 220954416, 222418904, 221056552, 220070456, 220400116, 220411513, 220952568, 220943346, 221727862, 222709611, 222701385