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Recall Observatory FDA recall evidence

Device product

DeRoyal CARDIAC LINEN PACK, REF 89-10543.02

Z-0691-2023

November 03, 2022

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 91134
Status
Ongoing
Classification
Class II
Quantity
204 kits
Official record key
device-enforcement:Z-0691-2023

Official wording

Reason: XXX

Code information: Lot Numbers: Lot 56336988 exp 11/1/2023; Lot 57188770 exp 8/1/2024; Lot 57393440 exp 5/1/2024; Lot 57644325 exp 7/1/2024

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