FDA-Device2023-05-03Class II
Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
Hazard
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.
Sold states
US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
Affected count
278 kits
Manufactured in
3000 E Sawyer Rd, N/A, Republic, MO, United States
Products
Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Number: 880424004, GS01031D - Thoracic.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1431-2023Don't want to check this manually?
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