Z-0942-2023 Class II Ongoing

Recalled by Stradis Healthcare — Waukegan, IL

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