Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1891-2021

April 29, 2021

Class II

Product summary

Firm
Medtronic Perfusion Systems
Event
Event 87915
Status
Terminated
Classification
Class II
Quantity
25 tubing packs
Official record key
device-enforcement:Z-1891-2021

Official wording

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

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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