Device product
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.
Z-1432-2023
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 91984
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 662 kits
- Official record key
device-enforcement:Z-1432-2023
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 #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.
Distribution pattern: US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
Derived failure modes
-
Unknown
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.