Steris recalls 200-pouch boxes of Vis-U-All High Temp Self Seal Pouches due to purple ink bleeding after steam processing, causing cosmetic defects and potential ink transfer to medical devices.
Purple ink located on the outside label of Vis-U-All Pouches may migrate ( bleed ) following steam processing causing cosmetic defects on the exterior of the pouch and in some instances, transference of the ink onto the device(s) contained within the pouch
Steris is recalling high-temperature self-seal pouches that may bleed purple ink after steam processing. This could cause cosmetic defects on the pouch and transfer ink to medical devices inside, though it's not a safety hazard.
Purple ink on the pouch label can bleed after steam processing. This may cause visible cosmetic defects on the pouch and transfer ink to medical devices inside, but it doesn't pose a safety risk.
Users of these pouches in medical settings who handle items requiring sterile packaging. The risk is highest for healthcare facilities using the pouches for medical procedures.
Check for model number 884039 on the pouch box. The lot numbers 200428A and 200628A are also associated with this recall.
Verify the model number on the pouch box is 884039.
No, the ink bleeding is cosmetic and doesn't cause safety risks. The recall is for potential cosmetic defects and ink transfer to medical devices.
The recall doesn't require immediate action. Check the model number and lot numbers to confirm if your pouches are affected.
Look for model number 884039 on the pouch box and lot numbers 200428A or 200628A.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-0793-2021 — Steris Steris Hello, I own a Steris that is covered by recall Z-0793-2021 from Steris. 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.
