Reported Apr 14, 2021 · Ongoing
Regard, Item Number 830067009, custom cardiovascular procedure kit
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, Item Number 830067009, custom cardiovascular procedure kit
- Lot codes and dates
- Lot number75818I
- Expiration Date05/18/2021
- Amount recalled
- 16 kits
Where it was sold
- Nationwide
- MO
Why it was recalled
ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment.
This product could cause temporary or reversible health problems — stop using it.
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