Medtronic Perfusion Systems: Medical Device Recall in 2021 - (Recall #: Z-1871-2021)

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 HY10Z48R2, Ctr., Custom Pack HY10Z48R2 Adult ECC 1/4, Custom Perfusion System, Sterile, Rx.

Product Classification:

Class II

Date Initiated: April 29, 2021

Date Posted: June 23, 2021

Recall Number: Z-1871-2021

Event ID: 87915

Reason for Recall:

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

Status: Terminated

Product Quantity: 6 tubing packs

Code Information:

GTIN 00763000292034, Lot #220866332, Use By 2022-09-29

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