ROi CPS recalls sterile surgical convenience kits where light handle covers may separate and fall off during use, posing a potential safety risk. Affected kits include specific models and lots; consumers should check their product details.
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 because the light handle covers may separate from the light handle and fall off during use. This could lead to the kit becoming unsafe or unusable during medical procedures.
The light handle covers are part of the surgical kit and may detach during use, potentially causing the light handle to become unstable or fall off. This could interfere with the surgical procedure and pose a minor risk to patient safety.
Surgical teams and medical facilities using the recalled sterile surgical convenience kits are most at risk. Patients and staff could be affected if the kit is used without the light handle covers staying securely attached.
Check for the following item numbers: 880353009 (GS00797I - Laparotomy Pk), 880429002 (GS01036B - Universal Custom), 800725004 (GS00930D - OH Base Robot Pack), 800725005 (GS00930E - OH Base Robot Pack), 800395003 (GS01000C - Colon Lithotomy), and 880391002 (GS00995B - Basic Laparotomy). Also, check the lot numbers and expiration dates listed in the recall notice.
Identify your kit's item number and lot number to confirm if it's affected by this recall.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use.
Check your kit's item number and lot number to see if it's affected. If it is, you should stop using it until you can get a replacement or fix.
Yes, the light handle covers may detach during use, which could cause the light handle to become unstable or fall off, potentially interfering with the surgical procedure.
We’ve drafted a message you can send ROi CPS to request your refund or repair — edit it as you like.
Subject: Recall Z-1432-2023 — ROi CPS ROi CPS Hello, I own a ROi CPS that is covered by recall Z-1432-2023 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.
