Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group
- Company
- Stradis Healthcare
- Recall Initiated
- December 15, 2022
- Posted
- January 11, 2023
- Recall Number
- Z-0942-2023
- Quantity
- 2,500 units
- Firm Location
- Waukegan, IL
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
US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.
Lot / Code Info
Assembly Number MAG-3000, UDI-DI: M752MAG30001, Lot Numbers: 220883387, 221226000, 220960490, 220986568, 222074682, 222458932
Root Cause
Process control
Action Taken
Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form.
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