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

Recall Z-0761-2018 — Vis-U-All High Temp 3.5"x9" Self Seal Pouch 200 pouches per box; 4 boxes per case Product Usage: The Vis-U-All High Temperature Sterilization Pouch is suitable for use by healthcare providers to enclose and seal medical devices to be sterilized by steam. The pouch is designed to maintain sterili

U.S. FDA — Device Enforcement · United States · 2017-06-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0761-2018
Date of alert: 2017-06-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Steris Corporation
Product category: device
Product type: Devices

Reported risk: On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All Pouches may migrate 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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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