Z-0942-2023 Class II Ongoing
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
- 2,500 units
Product Description
Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group
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 MAG-3000, UDI-DI: M752MAG30001, Lot Numbers: 220883387, 221226000, 220960490, 220986568, 222074682, 222458932