FDAFDA · Food and drugs·Recall number Z-1032-2016
PINPOINT Endoscopic Fluorescence Imaging System
Published March 9, 2016 · Recall initiated: January 29, 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
It has been determined that the PINPOINT Operator's Manual does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT laparoscopes and light guide cable in the reprocessing tray.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Novadaq Technologies Inc.
- Distributor
- Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Bangladesh, Canada, Hong Kong, India, and Israel.
- Lot
- Rev. J, Rev. K, Rev. L and Rev. M Model Number : PC9000
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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