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
FDA Recall Z-1158-2007 · Posted 2007-08-09
Recalling FirmDatascope Corporation
Recall StatusTerminated
Product CodeGEI
Date Initiated2007-05-07
Date Terminated2008-03-04
Product Quantity114
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Belgium, the Netherlands, and Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.