Class 2 Device Recall Covidien Precision Specimen Container

• Date Initiated by Firm: October 14, 2016
• Create Date: December 14, 2016
• Recall Status: Terminated on August 08, 2018
• Recall Number: Z-0756-2017
• Recall Event ID: 75481
• Product Classification: Container, specimen, sterile - Product Code FMH
• Product: Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile; Item Code: 17099
• Code Information: All lots starting with 3, 4, 5 and all lots from 600586264X to 613480164X
• Recalling Firm/ Manufacturer: Covidien LLC; 60 Middletown Ave; North Haven CT 06473-3908
• For Additional Information Contact: 203-492-5000
• Manufacturer Reason for Recall: Sterility of the outer surface of the container compromised due to packaging defect.
• FDA Determined Cause: Packaging process control
• Action: Covidien initiated recall by letter on October 14, 2016. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott Road, North Haven, CT 06473, Attention: Field Returns Department. Accounts requested to completed Recalled Product Return From to obtain an RGA. Questions: Contact your Medtronic representative or Customer Service at (800) 882-5878.
• Quantity in Commerce: 5,187,100 Units
• Distribution: Nationwide Foreign: Japan
• 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.