ROi CPS LLC recalls Core Biopsy 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 Core Biopsy Trays with certain lot numbers because the povidone-iodine swabsticks used in their production were out of specifications. This could affect medical safety during procedures.
The povidone-iodine swabsticks used in the production of these trays were out of specifications. This could lead to improper medical procedures if the swabsticks do not function correctly.
Medical professionals using the recalled Core Biopsy Trays with the listed lot numbers are most at risk. Patients undergoing procedures with these trays may also be affected.
Check the lot numbers on your Core Biopsy Tray: 88004C, 87367C, 869:86986C, 83380C, 83062C, 82614C, 86178C, and 85427C.
Identify your Core Biopsy Tray's lot number to see if it matches the recalled list: 88004C, 87367C, 86986C, 83380C, 83062C, 82614C, 86178C, or 85427C.
The povidone-iodine swabsticks used in the production of these Core Biopsy Trays were out of specifications.
Check the lot number on your Core Biopsy Tray to see if it matches the recalled list. If it does, contact ROi CPS LLC for further instructions.
The recall indicates the swabsticks were out of specifications, which could affect medical procedures, but specific risks are not detailed in the notice.
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-0251-2022 — ROi CPS LLC ROi CPS LLC Hello, I own a ROi CPS LLC that is covered by recall Z-0251-2022 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.
