Recall Z-1437-2023— ROi CPS LLC
Class II · Ongoing
Class II FDA medical device recall by ROi CPS LLC, initiated 2023-03-22. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- ROi CPS LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-22
- Firm location
- Republic, MO, United States
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.