FDAFDA · Food and drugs·Recall number Z-0710-2014
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occluding the duct with the balloon.
Published January 22, 2014 · Recall initiated: December 18, 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
Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.
- Lot
- Lot Number:16231178
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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