ROi CPS recalls sterile surgical convenience kits (Item 800753005, GY00958E) due to risk of light handle covers detaching during use. Affected units include lot #95517, expiring 10/17/2024.
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 800753005, GY00958E) because light handle covers may detach and fall off during use. This could cause the surgical light to become unstable or malfunction during procedures.
The light handle covers are a kit component that may separate from the light handle during use. If the covers fall off, the surgical light could become unstable or malfunction, potentially affecting the procedure.
Surgical teams using the recalled sterile surgical convenience kits for gynecological laparoscopy procedures are most at risk. The recall applies to kits sold with lot number 95517, expiring October 17, 2024.
Check for the item number 800753005 and model GY00958E on the kit. The recall applies to kits with lot number 95517 that expire on October 17, 2024.
Inspect the light handle covers for separation from the light handle. If they are loose or detached, stop using the kit immediately.
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 recalled kit has item number 800753005 and model GY00958E (WPH GYN Laparoscopy Pack).
The recalled kit expires on October 17, 2024 (lot #95517).
We’ve drafted a message you can send ROi CPS to request your refund or repair — edit it as you like.
Subject: Recall Z-1435-2023 — ROi CPS ROi CPS Hello, I own a ROi CPS that is covered by recall Z-1435-2023 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.
