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Recall Observatory FDA recall evidence

Device product

Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.

Z-1431-2023

March 22, 2023

Class II

Product summary

Firm
ROi CPS LLC
Event
Event 91984
Status
Ongoing
Classification
Class II
Quantity
278 kits
Official record key
device-enforcement:Z-1431-2023

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: 1. Lot #95475, exp. 10/29/2024, UDI (01)10194717112211(17)241029(10)95475. 2. Lot #95493, exp. 9/7/2024, UDI (01)10194717112327(17)240907(10)95493.

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.