Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Regard CV PK Recalled by ROi CPS LLC Due to Specific Regard kits contain the Gentige Chest Drain...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ROi CPS LLC directly.
Affected Products
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Quantity: 134 units
Why Was This 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.
Where Was This Sold?
This product was distributed to 1 state: MO
About ROi CPS LLC
ROi CPS LLC has 86 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report