Regard CV PK cardiovascular convenience kits with specific item numbers and lot numbers recalled due to insufficient setup instructions for chest drains, potentially causing injury.
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.
The Regard CV PK cardiovascular convenience kits with item numbers 880289014 and 880289015 are being recalled because their instructions for use don't provide enough safety steps for setting up catheters and patient connections. This could lead to injury if not used properly.
The recalled kits have instructions that don't adequately guide users on safely connecting catheters and patient tubes. This could lead to improper setup, potentially causing injury during medical procedures.
Patients using these kits for cardiovascular procedures are most at risk. Healthcare providers who use the kits for medical treatments may also be affected.
Check for item numbers 880289014 or 880289015 on the Regard CV PK cardiovascular convenience kits. The kits were sold with specific lot numbers: 94114, 95436 for one model and 96442 for the other.
Identify the item number and lot number on your Regard CV PK cardiovascular convenience kit to confirm if it's recalled.
The instructions for use do not provide sufficient precautions for properly setting up catheters and patient tube connections with single collection chamber chest drains.
The recall record does not specify a remedy, so check the kit details to see if it's affected and contact the manufacturer for further instructions.
Yes, the recalled kits have lot numbers 94114, 95436 for one model and 96442 for the other.
We’ve drafted a message you can send ROi CPS to request your refund or repair — edit it as you like.
Subject: Recall Z-0315-2024 — ROi CPS ROi CPS Hello, I own a ROi CPS that is covered by recall Z-0315-2024 from ROi CPS. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
