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Recall Observatory FDA recall evidence

Device product

DeRoyal HEART PACK, REF 89-8351.11

Z-0608-2023

November 03, 2022

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 91134
Status
Ongoing
Classification
Class II
Quantity
240 kits
Official record key
device-enforcement:Z-0608-2023

Official wording

Reason: XXX

Code information: Lot Numbers: Lot 56189105 exp 9/1/2024; Lot 57005558 exp 9/1/2024

Distribution pattern: US: Tennessee, Texas, New York, Wisconsin, Florida, Virginia, Massachusetts, Arizona, Missouri, Connecticut, New Jersey, Pennsylvania, North Carolina, Louisiana, Michigan, Minnesota, Ohio, Indiana, Kansas, Illinois, Alabama, Georgia, Mississippi

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    XXX