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Recall Observatory FDA recall evidence

Device product

regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit

Z-0307-2023

October 20, 2022

Class II

Product summary

Firm
ROi CPS LLC
Event
Event 91069
Status
Terminated
Classification
Class II
Quantity
243 kits
Official record key
device-enforcement:Z-0307-2023

Official wording

Reason: Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.

Code information: UDI/DI 10194717114789, Lot Numbers: 92274, exp 5/2/2024

Distribution pattern: LA, MO, NC, FL

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.