PlainRecalls
FDA Devices Moderate Class II Terminated

Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.

Reported: June 23, 2021 Initiated: April 29, 2021 #Z-1879-2021

Product Description

Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.

Reason for Recall

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

Details

Units Affected
15 tubing packs
Distribution
US Nationwide Distribution in the states of AL, AZ, CA, IN, KY, MA, OH, TN, and TX. There was no foreign/government/military distribution.
Location
Brooklyn Park, MN

Frequently Asked Questions

What product was recalled?
Medtronic CB10W63R1, Custom Pack CB10W63R1 HL 20 1/4, Custom Perfusion System, Sterile, Rx.. Recalled by Medtronic Perfusion Systems. Units affected: 15 tubing packs.
Why was this product recalled?
Specific lots may have been manufactured with insufficient or incomplete welds.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 23, 2021. Severity: Moderate. Recall number: Z-1879-2021.