ROi CPS LLC recalls specific ultrasound tray models with lots 87414C, 87035C, : 86918C, 88755C, and 85539C due to potential use of an out-of-specification povidone-iodine swabstick.
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
ROi CPS LLC has recalled certain ultrasound trays that used povidone-iodine swabsticks made by PDI, Inc. that were out of specifications. This could pose a risk if the swabsticks are not properly manufactured, though the exact hazard isn't specified in the recall.
The recall states that povidone-iodine swabsticks used in some ROi CPS ultrasound trays were out of specifications. This could mean the swabsticks don't meet quality standards, potentially leading to issues with their performance or safety during medical procedures.
Users of the recalled ultrasound trays, particularly medical professionals who use these devices in clinical settings, are most at risk due to potential improper swabstick function.
Check the lot numbers on your ultrasound tray: 87414C, 87035C, 86918C, 88755C, and 85539C. These specific models were affected by the recall.
Identify your ultrasound tray's lot number to see if it matches the recalled lots: 87414C, 87035C, 86918C, 88755C, or 85539C.
The recall states that povidone-iodine swabsticks used in some of these ultrasound trays were out of specifications, but the exact hazard isn't detailed.
Check the lot number on your ultrasound tray; if it matches 87414C, 87035C, 86918C, 88755C, or 85539C, it is affected.
The recall does not specify a remedy, so you should contact ROi CPS LLC directly for further instructions.
We’ve drafted a message you can send ROi CPS LLC to request your refund or repair — edit it as you like.
Subject: Recall Z-0255-2022 — ROi CPS LLC ROi CPS LLC Hello, I own a ROi CPS LLC that is covered by recall Z-0255-2022 from ROi CPS LLC. 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.
