ROi CPS LLC is recalling approximately 134 Regard Cardiovascular (CV) convenience kits because they contain Gentige Chest Drain products with inadequate instructions. These instructions do not provide necessary precautions for correctly setting up catheters and tube connections with the single collection chamber chest drains. This recall affects Regard CV PK kits with item numbers 880289014 and 880289015, which were distributed in Missouri.
Inadequate setup instructions for chest drains can lead to improper connection or setup of the drainage system. This could result in ineffective chest drainage or other medical complications for patients recovering from cardiovascular procedures.
Manufacturer Notification and Guidance
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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