Medtronic Perfusion Systems: Medical Device Recall in 2021 - (Recall #: Z-1892-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Medtronic BB8M63R5, Custom Pack BB8M63R5 Adult ECC, Custom Perfusion system, Sterile, Rx.

Product Classification:

Class II

Date Initiated: April 29, 2021

Date Posted: June 23, 2021

Recall Number: Z-1892-2021

Event ID: 87915

Reason for Recall:

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

Status: Terminated

Product Quantity: 2 tubing packs

Code Information:

GTIN 00763000458133, Lot number 221249911, Use By 2022-10-22

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.

Voluntary or Mandated:

Voluntary: Firm initiated