Class 2 Device Recall Covidien

• Date Initiated by Firm: August 06, 2015
• Date Posted: September 01, 2015
• Recall Status: Terminated on June 29, 2017
• Recall Number: Z-2537-2015
• Recall Event ID: 71893
• Product Classification: Saline, vascular access flush - Product Code NGT
• Product: MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Item Code: 8888104003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
• Code Information: Lot Numbers: 1504700147, 1507600096
• Recalling Firm/ Manufacturer: Covidien LLC; 60 Middletown Ave; North Haven CT 06473-3908
• For Additional Information Contact: Same; 203-492-5000
• Manufacturer Reason for Recall: Sterility may be compromised
• FDA Determined Cause: Packaging process control
• Action: Medtronic/Covidien sent an Urgent Medical Device Recall letter August 7, 2015 to affected customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter instructs customers to quarantine, discontinue use and return the affected product as instructed in the letter. For questions contact your Medtronic representative or Customer Service at (800)-882-5878
• Quantity in Commerce: 550 kits
• Distribution: US Nationwide Distribution
• 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.