FDAFDA · Food and drugs·Recall number Z-1355-2015
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
Published April 8, 2015 · Recall initiated: February 25, 2015
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
Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious patient risk for this issue is additional intervention for fragment retrieval using minimally invasive methods and, in some of the reported cases, this was performed to retrieve the device fragments.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Worldwide Distribution - US Distribution to the states of : CA, WI, FL and OH., and to the countries of: Belgium, Czech Republic, Finland, France, Germany, Great Britain, Italy, Spain, Switzerland, Austria, Hungary, Netherlands and Portugal.
- Lot
- UPN # LOT # H7493933108200 17245003, 17416605, 17489192 H7493933108350 17245004, 17245005, 17370709, 17408756 H749393310835K1 17411333, 17493554 H7493933110200 17318047 H7493933110350 17275822, 17438003, 17494025, 17501572 H749393311035K1 17328808, 17403871, 17416578, 17459144 H7493933110400 17275824, 17416608 H7493933112350 17245006, 17259580, 17275819 H7493933114350 17275815, 17338207 with Expiration Dates between January 30, 2016 and May 8, 2016
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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