Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes
Published October 26, 2016 · Recall initiated: May 18, 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
US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly distributed. The lot was assembled with internal catheter components which differ from the original Vari-Safe needle internal catheter components. All components are dimensionally similar to the original Vari-Safe needle internal catheter components and the components have history of use on other US Endoscopy needle products.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- US Endoscopy Group Inc
- Distributor
- US Distribution to the states of : OH, OR, WA and Internationally to the country of Italy.
- Lot
- Model #: 00711819; Lot 1520268
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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