FDAFDA · Food and drugs·Recall number Z-1995-2013
Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.
Published August 28, 2013 · Recall initiated: July 19, 2013
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
Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system during orthopedic knee surgery. The drapes are used to cover the Navio PFS system computer monitor and arm assembly and provide a sterile barrier in the surgical suite. The defect is evident when the computer monitor is being draped. The front section of the drape separates from the rest of the drape at
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Blue Belt Technologies MN
- Distributor
- Worldwide Distribution and US Nationwide in the states of: CA and PA. United Kingdom.
- Lot
- Lot: D130432, expires February 2018
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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