Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk;...
FDA Recall #Z-1432-2023 — Class II — March 22, 2023
Product Description
Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Universal Custom ; 3. regard Item Number: 800725004, GS00930D - OH Base Robot Pack ; 4. regard Item Number: 800725005, GS00930E - OH Base Robot Pack ; 5. regard Item Number: 800395003, GS01000C - Colon Lithotomy and 6. regard Item Number: 880391002, GS00995B - Basic Laparotomy.
Reason for Recall
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.
Recalling Firm
ROi CPS LLC — Republic, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
662 kits
Distribution
US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
Code Information
1. Lot #95322, exp. 10/29/2024, UDI (01)10194717105015(17)241029(10)95322; 2. Lot #95553, exp. 11/15/2024, UDI (01)10194717112389(17)241115(10)95553; 3. Lot #95438, exp. 10/29/2024, UDI (01)10194717110927(17)241029(10)95438; 4. Lot #95784, exp. 11/30/2024, UDI (01)10194717116837(17)241130(10)95784; 5. Lot #95767, exp. 10/29/2024, UDI (01)10194717112198(17)241029(10)95767; 6. Lot #95735, exp. 10/29/2024, UDI (01)10194717112174(17)241029(10)95735.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated