Z-1891-2021 Class II Terminated

Recalled by Medtronic Perfusion Systems — Brooklyn Park, MN

Recall Details

Product Type
Devices
Report Date
June 23, 2021
Initiation Date
April 29, 2021
Termination Date
March 20, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
25 tubing packs

Product Description

Medtronic CB10Y89R10, Custom Pack CB10Y89R10 ECC 3/8 A/V, Custom Perfusion System, Sterile, Rx.

Reason for Recall

Specific lots may have been manufactured with insufficient or incomplete welds.

Distribution Pattern

US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.

Code Information

GTIN 00763000499105, Lot numbers 221719701, Use By 2023-01-06; and 221764442, Use By 2023-01-13