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U.S. Department of Health and Human Services

Class 3 Device Recall Maquet Getinge Group

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  Class 3 Device Recall Maquet Getinge Group see related information
Date Initiated by Firm August 11, 2014
Date Posted September 03, 2014
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = DATASCOPE CORP.
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