Recall Z-1747-2014— NEO METRICS, INC.

Name: FDA recall Z-1747-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-31

Class II · Terminated

Class II FDA medical device recall by NEO METRICS, INC., initiated 2014-03-31, terminated 2015-01-16. It names one FDA 510(k) clearance: K133076. Product: 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: 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..

Recalling firm: NEO METRICS, INC.
Classification: Class II
Status: Terminated
Initiated: 2014-03-31
Terminated: 2015-01-16
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K133076 — NOVAGOLD HIGH PERFORMANCE GUIDEWIRENeometrics, Inc.·cleared 2014-02-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.