ROi CPS LLC recalls stereotactic trays with specific lot numbers due to povidone-iodine swabsticks used in production being 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 is recalling stereotactic trays with lot numbers 81985C, 80891C, and :80379C because the povidone-iodine swabsticks used in their manufacturing were out of specifications. This could affect medical procedures requiring precise surgical trays.
The povidone-iodine swabsticks used in manufacturing were out of specifications, which could lead to improper function of the stereotactic trays. This might affect surgical precision during procedures.
Medical professionals using stereotactic trays for surgical procedures are most at risk. Patients undergoing surgery with these trays may be affected if the swabsticks were used in production.
Check the lot numbers on the stereotactic tray: 81985C, 80891C, or 80379C. These trays were sold by ROi CPS LLC.
Identify the lot numbers on the stereotactic tray to see if they match 81985C, 80891C, or 80379C.
The povidone-iodine swabsticks used in manufacturing were out of specifications.
Check the lot numbers on the stereotactic tray. If it matches 81985C, 80891C, or 80379C, contact ROi CPS LLC for instructions.
The recall is due to out of specifications swabsticks, but the specific injury risk is not clearly described in the record.
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-0254-2022 — ROi CPS LLC ROi CPS LLC Hello, I own a ROi CPS LLC that is covered by recall Z-0254-2022 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.
