ROi CPS recalls sterile surgical convenience kits with item number 800718003 (GY00923C) due to risk of light handle covers separating and falling off during use.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
ROi CPS is recalling sterile surgical convenience kits (item number 800718003) because the light handle covers may separate from the light handle and fall off during use. This could lead to the kit becoming unusable or causing injury if the covers fall onto the surgical site.
The light handle covers are a kit component that may separate from the light handle during use and fall off. If the covers fall onto the surgical site, they could become a hazard during procedures. However, the risk is not described as causing serious injury in normal use.
Surgical professionals who use the recalled sterile surgical convenience kits are most at risk. The recall affects kits sold with item number 800718003 (GY00923C) and lot number 95437.
Check for the item number 800718003 (GY00923C) on the kit. The recall covers kits with lot number 95437 that expired November 15, 2024.
Inspect the light handle covers to ensure they are securely attached to the light handle.
The recall states the light handle covers may fall off during use, but it does not describe a risk of serious injury in normal use. The hazard is considered low risk.
Your kit is affected if it has item number 800718003 (GY00923C) and lot number 95437, which expired November 15, 2024.
The recall does not specify actions for if covers fall off. You should stop using the kit if covers become detached.
We’ve drafted a message you can send ROi CPS to request your refund or repair — edit it as you like.
Subject: Recall Z-1433-2023 — ROi CPS ROi CPS Hello, I own a ROi CPS that is covered by recall Z-1433-2023 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.
