Z-0938-2023 Class II Ongoing
FDA device recall Z-0938-2023 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: 112,675 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
- 112,675 units
Product Description
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
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 HCT3548-2, UDI-DI: M752HCT354821, Lot Numbers: 222770947, 221809694, 221938965, 221748547, 221578546, 221808445, 221386002, 222859338, 222940522, 221938972