Prollenium Medical Technologies recalls Revanesse Versa devices with incorrect 18-month expiration labels despite 12-month approval. Affected units have specific lot numbers and expiration dates.
Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.
Prollenium Medical Technologies recalls Revanesse Versa devices that are labeled with an 18-month expiration date, but the product is only approved for 12 months. This labeling error means some units may expire longer than intended, though it does not pose a safety risk.
The product is approved for 12 months but labeled with an 18-month expiration date. This mismatch could lead to confusion about when the product expires, but it does not cause harm or safety issues.
Users of Revanesse Versa devices with specific lot numbers and expiration dates listed in the recall. The risk is minimal as the issue is a labeling error, not a safety hazard.
Check the lot number and expiration date on your Revanesse Versa device. Affected units include specific lot numbers like 17K004 through 18G076 with expiration dates from July 2018 to June 2019.
Review the lot number and expiration date on your Revanesse Versa device to see if it matches the affected units listed in the recall.
The product is labeled with an 18-month expiration date, but it is approved for only 12 months. This labeling error does not pose a safety risk.
No, the recall is for labeling error only. There is no safety risk, so you do not need to stop using the device.
Check the expiration date and lot number on your device. If it matches the affected units listed, you can continue using it as there is no safety risk.
We’ve drafted a message you can send Prollenium to request your refund or repair — edit it as you like.
Subject: Recall Z-1146-2020 — Prollenium Prollenium Hello, I own a Prollenium that is covered by recall Z-1146-2020 from Prollenium. 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.
