Reported May 3, 2023 · Ongoing
Sterile surgical convenience kits
ROi CPS LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ROi CPS LLC · 3000 E Sawyer Rd · Republic, MO · 65738-2758
Is this the product you have?
Sterile surgical convenience kits
5 of 5 products
| Model / number | Product as published |
|---|---|
800756005 | regard , NU00961E - OH Laminectomy Cust Pack |
880411008 | regard , NU01018H - Lumbar Universal |
880396007 | regard , NU01001G - Craniotomy |
880387005 | regard , NU00991E - Ant/Cervical Spine ; and |
800716005 | regard , NU00921E - ORMC Major Crani Pack. |
- Lot codes and dates
5 of 5 products
Products covered by this recall # Barcodes Product as published 1 10194717111023Lot #95370, exp. 10/29/2024, UDI (01)10194717111023(17)241029(10)95370 2 10194717112242Lot #95477, exp. 6/30/2024, UDI (01)10194717112242(17)240630(10)95477 3 10194717114130Lot #95506, exp. 5/31/2024, UDI (01)10194717114130(17)240531(10)95506 4 10194717112709Lot #95632, exp. 5/30/2024, UDI (01)10194717112709(17)240530(10)95632; and 5 1019471711088010194717110880Lot #95646, exp. 11/15/2024, UDI (01)10194717110880(17)241115(10)95646, and Lot #95309, exp. 10/29/2024, UDI (01)10194717110880(17)241029(10)95309. - Amount recalled
- 456 kits
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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