Reported Aug 28, 2013 · Terminated
Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of…
Blue Belt Technologies MN
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Blue Belt Technologies MN · 2905 Northwest Blvd Ste 40 · Plymouth, MN · 55441-2673
Is this the product you have?
- Blue Belt Technologies, Inc
- Monitor Drape REFPFSD-V0001, Rx only, Sterile EO
- Product UsageThe intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting
- Lot codes and dates
- Lot
D130432expires February 2018
- Lot
- Amount recalled
- 60 cartons (20 pieces/carton) 40 in EU, 20 in US.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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