Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0791-2021 — Vis-U-All High Temp 6"x10" Heat Seal Pouch 200 pouches per box; 5 boxes per case Model Number: 883610

U.S. FDA — Device Enforcement · United States · 2020-12-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0791-2021
Date of alert
2020-12-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Steris Corporation
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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