Steris recalls 200-pouch boxes of Vis-U-All High Temp Self-Seal Pouches due to purple ink bleeding after steam processing, potentially leaving ink on 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 ink to transfer to medical devices, though the risk is cosmetic and not harmful to users.
Purple ink on the pouch label can bleed after steam processing, causing visible stains on the pouch itself and potentially transferring ink to medical devices inside. This is a cosmetic issue that doesn't affect device function or safety.
Users of medical sterilization pouches, particularly those in healthcare settings. The risk is low for most users as the ink transfer is cosmetic and not harmful.
Check for model number 884515 on the pouch packaging. The product was sold with lot number 200536A in 2005.
Look for model number 884515 and lot number 200536A on the packaging.
No, the ink transfer is cosmetic and does not affect device safety or function.
Check for model number 884515 and lot number 200536A on the packaging.
The recall does not require action as the ink transfer is cosmetic and not harmful.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-0797-2021 — Steris Steris Hello, I own a Steris that is covered by recall Z-0797-2021 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.
