Steris recalls 200-pouch boxes of Vis-U-All High Temp Self Seal Pouches due to purple ink bleeding during 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 when exposed to steam. This could cause cosmetic damage to the pouches and transfer ink to medical devices inside, though it doesn't pose a safety risk.
Purple ink on the pouch label can bleed during steam processing, creating visible stains on the pouch itself and potentially transferring ink to medical devices inside. This is a cosmetic issue that doesn't compromise device function or safety.
Users of medical-grade pouches for sterilization, particularly those in healthcare settings. The risk is minimal as the ink transfer is cosmetic and doesn't affect device safety.
Check for Vis-U-All High Temp 5.5"x10" Self Seal Pouches with model number 884510 and lot numbers 200435A or 200635A. These were sold in boxes of 200 pouches, with 4 boxes per case.
Look for model number 884510 and lot numbers 200435A or 200635A on the pouch label.
No, the ink transfer is cosmetic and does not affect device safety or function.
Check for model number 884510 and lot numbers 200435A or 200635A on the pouch label.
No, the recall is for cosmetic defects only; these pouches can still be used safely.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-0796-2021 — Steris Steris Hello, I own a Steris that is covered by recall Z-0796-2021 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.
