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

Recall Z-1041-2016 — Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into co

U.S. FDA — Device Enforcement · United States · 2016-02-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1041-2016
Date of alert
2016-02-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Volcano Corporation
Product category
device
Product type
Devices
Reported risk: Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.