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ROi CPS LLC recalls Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regar
Recalled May 3, 2023 · FDA recall Z-1437-2023 · ROi CPS
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. · FDA Class II
Units
456 kits
Sold at
US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution.
Description
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.
Product
Sterile surgical convenience kits: 1. regard Item Number: 800756005, NU00961E - OH Laminectomy Cust Pack; 2. regard Item Number: 880411008, NU01018H - Lumbar Universal ; 3. regard Item Number: 880396007, NU01001G - Craniotomy ; 4. regard Item: 880387005, NU00991E - Ant/Cervical Spine ; and 5. regard Item Number: 800716005, NU00921E - ORMC Major Crani Pack.
Manufacturer(s)
ROi CPS LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →