The ClearGlide EVH small with Scissors. The kit includes three Precision Bipolar Devices, an Optical Vessel Dissector, a
FDA device recall Z-1157-2007 · posted 2007-08-09 · Terminated
Recall details
- Recalling firm
- Datascope Corporation
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 549
- Distribution
- Worldwide, including USA, Belgium, the Netherlands, and Germany.
- Date initiated
- 2007-05-07
- Date posted
- 2007-08-09
- Date terminated
- 2008-03-04
- Location
- Fairfield, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLEARGLIDE PRECISION BIPOLAR DEVICE (K003587) | ETHICON, Inc. | 2000-12-04 |