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 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 may bleed after steam processing, creating cosmetic defects on the pouch itself. In some cases, the ink can transfer to medical devices inside the pouch during processing.
Users of Steris Vis-U-All High Temp Self-Seal Pouches for medical devices are affected. Those using the pouches in steam processing environments are most at risk.
Check for model number 884411 on the pouch packaging. The product was sold with lot number 200434A in 2004.
Look for model number 884411 on the pouch packaging to confirm if it's recalled.
No, the ink bleeding causes cosmetic defects and potential ink transfer to medical devices, but it does not pose a safety risk.
Check for model number 884411 on the pouch packaging and lot number 200434A from 2004.
The recall does not specify a remedy, so no action is required beyond checking if you have the recalled model.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-0795-2021 — Steris Steris Hello, I own a Steris that is covered by recall Z-0795-2021 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.
