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 because purple ink on the label may bleed after steam processing. This could cause cosmetic defects on the pouch and potentially transfer ink to medical devices inside.
Purple ink on the pouch label can migrate to the pouch exterior and sometimes transfer to medical devices after steam processing. This causes cosmetic defects but does not pose a safety risk to users.
Users of these pouches for medical sterilization are affected. The risk is highest for healthcare facilities using the pouches for equipment sterilization.
Check for model number 884713 on the pouch box. The lot numbers 200437A and 200637A are also associated with this recall.
Look for model number 884713 and lot numbers 200437A or 200637A on the pouch box.
Purple ink on the pouch label may bleed after steam processing, causing cosmetic defects and potential ink transfer to medical devices inside.
This is a low-risk issue that causes cosmetic defects and possible ink transfer to medical devices, but does not pose a safety risk to users.
Check for model number 884713 and lot numbers 200437A or 200637A on the pouch box.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-0798-2021 — Steris Steris Hello, I own a Steris that is covered by recall Z-0798-2021 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.
