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Recall Observatory FDA recall evidence

Device product

Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

Z-0783-2021

November 13, 2020

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 86826
Status
Terminated
Classification
Class II
Quantity
360
Official record key
device-enforcement:Z-0783-2021

Official wording

Reason: The cylindrical sponge component is not x-ray detectable.

Code information: Lot 20GBG768 (Expiration: 11/30/2021); 20HBO067 (Expiration: 02/28/2022); Lot 20IBC642 (Expiration 03/31/2022)

Distribution pattern: Foreign distribution only - Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The cylindrical sponge component is not x-ray detectable.