FDAFDA · Food and drugs·Recall number 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 contact with them.
Published March 9, 2016 · Recall initiated: February 5, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Volcano Corporation
- Distributor
- Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.
- Lot
- REF numbers: PBKGB and PBKBG-10 (10 pack): all lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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