Recall Z-1156-2007
Datascope Corporation · initiated May 7, 2007
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
Codes / lots: 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.
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: Other
Action taken
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.
Details
- Recall number
- Z-1156-2007
- Initiated
- May 7, 2007
- Posted by FDA
- August 9, 2007
- Terminated
- March 4, 2008
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 1008
- Distribution
- Worldwide, including USA, Belgium, the Netherlands, and Germany.
- Recalling firm
- Datascope Corporation, Fairfield, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1157-2007 | The ClearGlide EVH small with Scissors. The kit includes three Precision Bipolar…Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device.… | 05/07/2007Terminated |
| Z-1158-2007 | Precision Bipolar Device 6 pack Consists of a six-pack of the Precision Bipolar Device.…Datascope has experienced a higher than usual number of reports involving the Precision Bipolar Device.… | 05/07/2007Terminated |