Z-1747-2014 Class II Terminated
FDA device recall Z-1747-2014 was initiated by NEO METRICS, INC. on March 31, 2014 and is designated Class II. 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. The recall status is terminated (terminated January 16, 2015). Affected quantity: 1256 boxes ( 2 wires/box).
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