ROi CPS recalls convenience kits with regard IV Start Kits (item numbers 830014015 and 830014016) due to potential inadequacy in test method validation during manufacturing.
A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.
ROi CPS has recalled convenience kits containing regard IV Start Kits because the manufacturing process may not have properly validated the test methods used. This could affect the safety and reliability of the kits.
The recall is based on potential inadequacy in the validation of test methods used during manufacturing. This could mean the kits might not function as intended, but the specific risk to users is not clearly described in the notice.
Healthcare professionals and facilities using the recalled convenience kits are likely affected. Those handling the kits during medical procedures face the highest risk.
Check for item numbers 830014015 or 830014016 on the kits. The kits were sold with specific lot numbers and expiration dates listed in the recall notice.
Identify the item number and lot number on the kit to confirm if it is recalled.
The manufacturer identified potential inadequacy in the validation of test methods used during manufacturing.
The recall notice does not specify a remedy, so check the product details to confirm if it is affected.
The recall indicates a potential issue with manufacturing validation, but the specific safety risks are not clearly described in the notice.
We’ve drafted a message you can send ROi CPS to request your refund or repair — edit it as you like.
Subject: Recall Z-1004-2022 — ROi CPS ROi CPS Hello, I own a ROi CPS that is covered by recall Z-1004-2022 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.
