Class 3 Device Recall Maquet Getinge Group

• Date Initiated by Firm: August 11, 2014
• Date Posted: September 03, 2014
• Recall Status: Terminated on February 05, 2015
• Recall Number: Z-2568-2014
• Recall Event ID: 69072
• 510(K)Number: K041281
• Product Classification: System, balloon, intra-aortic and control - Product Code DSP
• Product: LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
• Code Information: Part Number - 0684-00-0480-01U
• Recalling Firm/ Manufacturer: Datascope Corporation; 15 Law Dr; Fairfield NJ 07004-0011
• For Additional Information Contact: Ms. Karen LeFevere; 973-244-6100
• Manufacturer Reason for Recall: During label reconciliation a duplicate serial number label was detected to be printed for the LINEAR 7.5 FR 40 cc Intra-Aortic Balloon Catheter.
• FDA Determined Cause: Labeling False and Misleading
• Action: Maquet Inc.is sued an Urgent Medical Device Recall Letter/ Fax Back Form dated August 11, 2014. Customers are asked to quarantine the affected product and upon return they will be provided with an exchanged unaffected product. The attached form should be completed an returned to Maquet Inc. Questions can be directed to Maquet Technical Support at (888) 627-8383 - Press option "3" followed by option "1" Monday through Friday between the hours of 8 am and 5 pm (EST).
• Quantity in Commerce: one unit
• Distribution: US Distribution to TX.
• 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.

• 510(K) Database: 510(K)s with Product Code = DSP