Steris recalls 200-pouch boxes of Vis-U-All High Temp Heat 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 heat seal pouches because purple ink on the label can bleed after steam processing. This may cause ink to transfer to medical devices inside the pouch, creating cosmetic defects.
Purple ink on the pouch label can migrate to the pouch exterior and transfer to medical devices after steam processing. This causes cosmetic defects but does not pose a health risk to users.
Users of medical devices that might be packaged in these pouches, particularly healthcare facilities using the product for sterilization.
Check for model number 883610 on the pouch box. Look for lot numbers 200424A or 200524A on the box.
Inspect the pouch label for purple ink that may bleed after steam processing.
No, the ink transfer only causes cosmetic defects and does not pose a health risk.
Look for model number 883610 and lot numbers 200424A or 200524A on the box.
The recall does not specify a remedy, so no action is required beyond checking for the model and lot numbers.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-0791-2021 — Steris Steris Hello, I own a Steris that is covered by recall Z-0791-2021 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.
