ROi CPS LLC recalls REGARD Ear Tray with specific lot numbers due to using a povidone-iodine swabstick that was out of specifications.
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 REGARD Ear Trays because they contain a povidone-iodine swabstick that was manufactured out of specifications. This could pose a risk if the swabstick does not meet quality standards.
The recalled REGARD Ear Trays include a povidone-iodine swabstick that was manufactured out of specifications. This means the swabstick may not meet quality standards, potentially affecting its safety and effectiveness.
Owners of REGARD Ear Trays with lot numbers 88400C, 87798C, 86311C, or 88537C are affected. People using these ear trays for medical purposes may be at higher risk.
Check the lot number on your REGARD Ear Tray. The affected lots are 88400C, 87798C, 86311C, and 88537C.
Identify the lot number on your REGARD Ear Tray to see if it matches the affected lots: 88400C, 87798C, 86311C, or 88537C.
The affected lot numbers are 88400C, 87798C, 86311C, and 88537C.
The product was recalled because it contains a povidone-iodine swabstick that was manufactured out of specifications.
The recall record does not specify a remedy, so you should check the lot number and contact ROi CPS LLC 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-0252-2022 — ROi CPS LLC ROi CPS LLC Hello, I own a ROi CPS LLC that is covered by recall Z-0252-2022 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.
