ROi CPS recalls custom procedure packs with banded 4x4 Raytec 16ply gauze sponges that may flake or fray. Affected items include specific models and lot numbers listed in the recall notice.
Gauze sponges contained in custom kits may be flaking or fraying.
ROi CPS is recalling custom procedure packs that contain banded 4x4 Raytec 16ply gauze sponges. These sponges may flake or fray, which could lead to skin irritation or infection if used improperly.
The gauze sponges in the packs can flake or fray, potentially causing skin irritation or infection if they break off during medical procedures. This is a minor hazard that does not pose a serious injury risk under normal use.
Healthcare professionals who use these custom procedure packs for medical procedures are most likely affected. Patients using the packs during surgeries or medical treatments may also be at risk if the sponges become flaky or frayed.
Check for custom procedure packs with banded 4x4 Raytec 16ply gauze sponges. Affected items include specific models like 'Regard, PACEMAKER' (Item 800221010, Lot #82466) and other listed items with corresponding lot numbers.
Identify the specific model and lot number of the custom procedure pack to confirm if it is affected.
The gauze sponges may flake or fray, which could cause skin irritation or infection if they break off during medical procedures.
Custom procedure packs with banded 4x4 Raytec 16ply gauze sponges, including specific models like 'Regard, PACEMAKER' (Item 800221010, Lot #82466) and other listed items with corresponding lot numbers.
No, the hazard is low risk. You can continue using the products but should check the model and lot number to confirm if they are affected.
We’ve drafted a message you can send ROi CPS to request your refund or repair — edit it as you like.
Subject: Recall Z-0737-2021 — ROi CPS ROi CPS Hello, I own a ROi CPS that is covered by recall Z-0737-2021 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.
