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Recall Observatory FDA recall evidence

Device product

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

Z-1892-2021

April 29, 2021

Class II

Product summary

Firm
Medtronic Perfusion Systems
Event
Event 87915
Status
Terminated
Classification
Class II
Quantity
2 tubing packs
Official record key
device-enforcement:Z-1892-2021

Official wording

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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