Steris recalls 200-pouch heat seal pouches where purple ink on labels may bleed after steam processing, causing cosmetic issues and potential ink transfer to devices. Affected units have model 883411 and lot numbers 200421A/200521A.
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 have purple ink bleeding after steam processing. This can cause cosmetic defects on the pouch and potentially transfer ink to devices inside. The issue does not pose a safety risk but affects appearance and device cleanliness.
Purple ink on the pouch label can migrate to the pouch exterior and sometimes onto devices inside after steam processing. This causes cosmetic defects and potential ink transfer, but does not cause injury or damage to the device.
Users of Steris Vis-U-All High Temp 4.5"x11" Heat Seal Pouches with model number 883411 and lot numbers 200421A or 200521A are affected. Those using these pouches for medical or laboratory purposes may see ink transfer to devices.
Check for model number 883411 and lot numbers 200421A or 200521A on the pouch packaging. The product comes in boxes of 200 pouches per box and 5 boxes per case.
Look for model number 883411 and lot numbers 200421A or 200521A on the pouch packaging.
No, the recall only addresses cosmetic defects and potential ink transfer to devices, not safety hazards.
Check for model number 883411 and lot numbers 200421A or 200521A on the pouch packaging.
The recall does not specify a remedy, so no action is required beyond checking the label.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-0790-2021 — Steris Steris Hello, I own a Steris that is covered by recall Z-0790-2021 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.
