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Recall Observatory FDA recall evidence

Device product

Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

Z-0781-2021

November 13, 2020

Class II

Product summary

Firm
Medline Industries Inc
Event
Event 86826
Status
Terminated
Classification
Class II
Quantity
40
Official record key
device-enforcement:Z-0781-2021

Official wording

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

Code information: Lot 20HBM370 (Expiration 02/28/2025); 20IBB678 (Expiration 03/31/2025); 20KBP338 (Expiration Date: 05/31/2025 never distributed)

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.