Class 2 Device Recall JosNoe Medical PS500 Scope Warmer

• Date Initiated by Firm: December 01, 2015
• Date Posted: January 30, 2016
• Recall Status: Terminated on March 22, 2016
• Recall Number: Z-0732-2016
• Recall Event ID: 73007
• Product Classification: Laparoscopic accessories, gynecologic - Product Code NWV
• Product: PS-500 Scope Warmer; 10 units per box.; ; Pre-heating scope for laparoscopy surgery.
• Code Information: Lot# G154341 Exp: 4/14/18
• Recalling Firm/ Manufacturer: JosNoe Medical, Inc.; 1303 S Main St; Chelsea MI 48118-1483
• For Additional Information Contact: Noelle Temple; 734-475-7403
• Manufacturer Reason for Recall: Damage to package seals potentially compromising sterility.
• FDA Determined Cause: Packaging process control
• Action: On 12/1/2015, notifications were sent to the affected customers via e-mail. The recall notification included a description of the reason for the recall, the affected product, and instructions for identifying and returning the affected product.
• Quantity in Commerce: 1008 boxes
• Distribution: Distributed US (nationwide) and in Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.