ROi CPS recalls sterile cardiac catheter surgical kits with item number 880393003 where light handle covers may detach during use. Affected kits were sold with lot #95383, expiring 10/29/2024.
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 kits for cardiac catheter procedures because the light handle covers might detach during use. This could lead to the covers falling off and potentially causing injury if they become a hazard during surgery.
The light handle covers are part of the surgical kit and may separate from the light handle during use. If they fall off, they could become a hazard during surgery, potentially causing injury to the patient or staff.
Surgical teams using the recalled cardiac catheter kits are most at risk. Patients undergoing procedures with these kits could be affected if the covers fall off.
Check for the item number 880393003 and lot number 95383 on the kit packaging. The kits were sold with an expiration date of 10/29/2024.
Look for item number 880393003 and lot number 95383 on the kit packaging.
The recall states the light handle covers may fall off during use, so it is not safe to use without checking if it's recalled.
The recall does not specify a remedy, so check the kit packaging for item number 880393003 and lot number 95383 to confirm if it's affected.
The kits were sold with an expiration date of 10/29/2024.
We’ve drafted a message you can send ROi CPS to request your refund or repair — edit it as you like.
Subject: Recall Z-1434-2023 — ROi CPS ROi CPS Hello, I own a ROi CPS that is covered by recall Z-1434-2023 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.
