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Recall Observatory FDA recall evidence

Device product

Sterile surgical convenience kit: regard Item Number: 800718003, GY00923C - WPH Major Vaginal Pack.

Z-1433-2023

March 22, 2023

Class II

Product summary

Firm
ROi CPS LLC
Event
Event 91984
Status
Ongoing
Classification
Class II
Quantity
70 kits
Official record key
device-enforcement:Z-1433-2023

Official wording

Reason: The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

Code information: Lot #95437, exp. 11/15/2024, UDI (01)10194717110903(17)241115(10)95437.

Distribution pattern: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.