ROi CPS recalls Isolation Droplet Bundle Kit (item 830006013, lot 78253M) due to incorrect expiration date labeling that may lead to using expired components.
Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.
ROi CPS is recalling specific Isolation Droplet Bundle Kits because they have an incorrect expiration date label. This could mean using expired components, which might not be safe for procedures.
The kits are labeled with an expiration date that is later than the soonest expiring component. This means users might use components that have already expired, potentially leading to unsafe procedures.
Users of the recalled Isolation Droplet Bundle Kit (item : 830006013, lot 78253M) who are performing custom procedures. Those using the kit without checking expiration dates are at risk of using expired components.
Check for the Isolation Droplet Bundle Kit with item number 830006013 and lot number 78253M. The kit may have an expiration date label that is later than the soonest expiring component.
Verify the expiration date label on the kit matches the soonest expiring component.
ROi CPS has found a labeling error where the expiration date on the kit is later than the soonest expiring component.
Check the expiration date label to ensure it matches the soonest expiring component. If it doesn't, stop using the kit.
The recall does not provide a fix; users must check expiration dates themselves.
We’ve drafted a message you can send ROi CPS to request your refund or repair — edit it as you like.
Subject: Recall Z-2465-2020 — ROi CPS ROi CPS Hello, I own a ROi CPS that is covered by recall Z-2465-2020 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.
