Z-1885-2021 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
11 tubing packs

Product Description

Medtronic HY10Y54R4, Custom Pack HY10Y54R4 ECC PED 1/4, 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 00763000306717, Lot number 221387881, Use By 2022-10-21