FDAMarch 22, 2023device
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. reg...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
roi cpsroi
UPCs
1019471711102310194717112242101947171141301019471711270910194717110880
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAregard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.2024-12-26
- FDAregard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 8002230092024-07-24
- FDARegard Kit containing the Microtek decanter2024-06-17
- FDAregard Operative LAP, Item Number 800943001; surgical convenience kit2023-12-18
- FDARegard Dressing change kit, Item Number 8000260062023-11-20
- FDARegard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit2023-09-21
- FDAGS0008 2Y - Burn Pack - STL, Item Number 8800820252023-09-11
- FDASterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D - Total Hip; 3. regard Item Number: 880427003, OR01034C - Total Knee; 4. regard Item Number: 880474001, OR01106A - Knee Arthroscopy; 5. regard Item Number...2023-03-22
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