Steris recalls 200-pouch heat seal pouches with purple ink that may bleed after steam processing, causing cosmetic defects and ink transfer to devices. Affected units have model 883713 and lot numbers 200425A or 200625A.
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 heat seal pouches that may bleed purple ink after steam processing, potentially transferring ink to devices inside. This could cause cosmetic issues and ink residue on equipment, but does not pose a safety risk.
Purple ink on the pouch label can migrate after steam processing, creating cosmetic defects and transferring ink to devices inside the pouch. This may cause visible ink residue on equipment but does not affect safety or function.
Users of Steris Vis-U-All High Temp pouches with model number 883713 and lot numbers 200425A or 200625A are affected. Healthcare facilities using these pouches for sterilization are most at risk.
Check for model number 883713 and lot numbers 200425A or 200625A on the pouch packaging. The pouches come in sets of 200 per box and 5 boxes per case.
Verify model number 883713 and lot numbers 200425A or 200625A on the pouch packaging.
Purple ink on the pouch label may bleed after steam processing, causing cosmetic defects and ink transfer to devices inside the pouch.
No, the ink transfer is cosmetic and does not affect safety or functionality of the device.
Look for model number 883713 and lot numbers 200425A or 200625A on the pouch packaging.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-0792-2021 — Steris Steris Hello, I own a Steris that is covered by recall Z-0792-2021 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.
