Date Initiated by Firm |
May 07, 2007 |
Date Posted |
August 09, 2007 |
Recall Status1 |
Terminated 3 on March 04, 2008 |
Recall Number |
Z-1158-2007 |
Recall Event ID |
38005 |
510(K)Number |
K003587
|
Product Classification |
endoscopic vessel harvesting system - Product Code GEI
|
Product |
Precision Bipolar Device 6 pack Consists of a six-pack of the Precision Bipolar Device. Manufactured for: Datascope Cardiac Assist 15 Law Drive Fairfield, NJ 07004-0011 |
Code Information |
Part number PBD01 Lot number 12517, Exp. 5/13/09; 12512m |
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 |
114 |
Distribution |
Worldwide, including USA, Belgium, the Netherlands, and Germany. |
Total Product Life Cycle |
TPLC Device Report
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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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