Z-0937-2023 Class II Ongoing
FDA device recall Z-0937-2023 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: 2,779 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
- 2,779 units
Product Description
HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. 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 HCT2050, UDI-DI: M752HCT20502, Lot Number: 220130152, 221677841