Steris recalls 200-pouch boxes of Vis-U-All High Temp 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 develop purple ink bleeding 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 the pouch. The ink transfer is not a safety hazard but could affect device appearance or cleaning.
Users of these pouches in medical settings who handle sterilized equipment. The risk is highest for facilities using the pouches for medical device sterilization.
Check for model number 884816 on the pouch box. The product was sold with lot number 200438A. Each box contains 200 pouches and 4 boxes make one case.
Look for model number 884816 on the pouch box and lot number 200438A.
No, the ink bleeding causes cosmetic defects and potential ink transfer to medical devices but does not pose a safety risk.
Check for model number 884816 on the pouch box and lot number 200438A. Each box contains 200 pouches and 4 boxes make one case.
The recall does not require action, but you can check the label to confirm if your product is affected.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-0799-2021 — Steris Steris Hello, I own a Steris that is covered by recall Z-0799-2021 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.
