SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are par

FDA device recall Z-0227-2015 · posted 2014-11-19 · Terminated

Recall details

Recalling firm: Monteris Medical Corp
Reason for recall: Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.
Action taken: Monteris Medical sent an Urgent Advisory Notice of Product Recall letter dated October 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by user: Our distribution records document that you were shipped products from the affected lots. Please check your inventory to confirm whether you have any stock affected by this notice. An acknowledgment form is included to assist you in the assessment of your inventory. Your Monteris Medical Sales Representative will be glad to assist you with this assessment. Once your inventory has been verified, please fax the form back to Monteris Medical at 763-253-4728.
Root cause: Process control
Status: Terminated
Product code: GEX
Quantity affected: 234 devices
Distribution: US Distribution including the states of CA, CT, FL, GA, KS, MN, MO, NC, OH, PA, TX, and VA
Date initiated: 2014-10-03
Date posted: 2014-11-19
Date terminated: 2014-12-08
Location: Plymouth, MN

Recalls and clearances share one API, with change alerts when new recalls post.