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Recall Observatory FDA recall evidence

Device product

regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit

Z-0300-2023

October 20, 2022

Class II

Product summary

Firm
ROi CPS LLC
Event
Event 91069
Status
Terminated
Classification
Class II
Quantity
32 kits
Official record key
device-enforcement:Z-0300-2023

Official wording

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

Code information: UDI/DI 10194717101611, Lot Numbers: 92674, exp 9/30/2023; 93459, exp 9/30/2023,

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.