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Recall Observatory FDA recall evidence

Device product

DeRoyal BASIC EYE PACK, REF 89-8337.09

Z-0607-2023

November 03, 2022

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 91134
Status
Ongoing
Classification
Class II
Quantity
50 kits
Official record key
device-enforcement:Z-0607-2023

Official wording

Reason: XXX

Code information: Lot Numbers: Lot 57118632 exp 9/1/2024; Lot 57184285 exp 12/1/2024; Lot 57630628 exp 4/1/2025; Lot 57745978 exp 4/1/2025: Lot 57688413 exp 12/01/2024

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