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U.S. Department of Health and Human Services

Class 2 Device Recall Precision Bipolar Device ClearGlide EVH

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  Class 2 Device Recall Precision Bipolar Device ClearGlide EVH see related information
Date Initiated by Firm May 07, 2007
Date Posted August 09, 2007
Recall Status1 Terminated 3 on March 04, 2008
Recall Number Z-1156-2007
Recall Event ID 38005
510(K)Number K003587  
Product Classification endoscopic vessel harvesting system - Product Code GEI
Product Precision Bipolar Device
ClearGlide EVH Small (endoscopic vessel harvesting system)
The kit included three Precision BiPolar Devices, an Optical Vessel Dissector, a Small Ultra Retractor and a Vessel Dissector.
Datascope Cardiac Assist
Sterile R
Manufactured for:
Datascope Cardiac Assist
15 Law Drive
Fairfield, NJ 07004
Code Information Part number KTV 15 Lot numbers: 12499, Exp. 4/21/09; 12500, Exp. 4/22/09; 12501, Exp. 4/27/09; 12504, Exp. 5/04/09 and 12505, Exp. 5/13/09.
Recalling Firm/
Manufacturer		 Datascope Corporation
15 Law Dr
Fairfield NJ 07004-0011
For Additional Information Contact Nancy Cohen
973-244-6104
Manufacturer Reason
for Recall		 Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device. Reports include the locking or sticking of the buttons of the device which operate the jaws, particularly when a side load is placed on the shaft of the device.
FDA Determined
Cause 2		 Other
Action Letters were sent to all hospitals, (contact: Hospital Administrators) the week of May 7, 2007 (certified mail, Return Receipt requested) with Urgent Medical Device Field Correction. The letter requests that all potential users of the devices at the institution be mdae aware of the situation. The letter instructs clinicians what to do if they experience problems with locking buttons of the Precision Device and also if the device is clamped closed on a vein branch and cannot be opened. Institutions are also requested to sign and return a postal card acknowledging receipt of the Field Correct notification and Datascope provides telephone numbers for customer service.
Quantity in Commerce 1008
Distribution Worldwide, including USA, Belgium, the Netherlands, and Germany.
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 = GEI and Original Applicant = ETHICON, INC.
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