FDA (Devices) recall action 86942
The FDA (Devices) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.
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
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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing.
Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices.
Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may bleed after steam processing, causing cosmetic defects and potential ink transfer to devices.
Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects or ink transfer to devices.
Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may migrate during steam processing, causing cosmetic defects and potential ink transfer to devices.
Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the outside label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices.
Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing.
Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices.
Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may bleed during steam processing.
Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing.
Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing.
Steris Corporation is recalling Vis-U-All High Temp Self Seal Pouches because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices.
Steris Corporation is recalling Vis-U-All High Temp Heat Seal Pouches because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices inside.
Steris Corporation is recalling Vis-U-All High Temperature Tubing because purple ink on the exterior label may bleed during steam processing, causing cosmetic defects and potential ink transfer to devices inside the pouch.