Reported Nov 24, 2021 · Terminated
REGARD Stereotactic Tray
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?
- REGARD Stereotactic Tray
- Lot codes and dates
- Lots numbers
81985C80891C and 80379C
- Lots numbers
- Amount recalled
- 175 trays
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
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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