Z-1747-2014 Class II Terminated

Recalled by NEO METRICS, INC. — Plymouth, MN

Recall Details

Product Type
Devices
Report Date
June 18, 2014
Initiation Date
March 31, 2014
Termination Date
January 16, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1256 boxes ( 2 wires/box)

Product Description

Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

Reason for Recall

Neo Metrics, Inc. is recalling NovaGold Guidewire because the tip may uncoil and / detach more frequently than anticipated. There have been no reports of illness or injury.

Distribution Pattern

Worldwide Distribution - US and the countries of Austria, Belgium, Germany, Spain, France, Great Britain, Italy, Netherlands and Sweden.

Code Information

MO26343, MO26345, MO26724, MO27402, MO26342, MO26344, MO26731, MO27401, MO27660, MO27901, MO27659, MO27820, MO27899