Reported Nov 22, 2023 · Ongoing
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience 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 CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
- Lot codes and dates
- a) UDI/DI 10194717111702
- Lot Numbers
9411495436b) UDI/DI 10194717117049
- Lot Numbers96442
- Amount recalled
- 134 units
Where it was sold
Why it was recalled
Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.
This product could cause temporary or reversible health problems — stop using it.
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