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Recall Observatory FDA recall evidence

Device product

Medtronic BB10R94R6, Custom Pack BB10R94R6 1/4 ECCPK, Custom Perfusion System, Sterile, Rx.

Z-1873-2021

April 29, 2021

Class II

Product summary

Firm
Medtronic Perfusion Systems
Event
Event 87915
Status
Terminated
Classification
Class II
Quantity
10 tubing packs
Official record key
device-enforcement:Z-1873-2021

Official wording

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

Code information: GTIN 00763000258016, Lot numbers 221102356, Use By 2022-10-09; and 221672011, 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.