EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR. Tapered to 4.5FR. Length: 138-
FDA device recall Z-0079-04 · posted 2003-10-31 · Terminated
Recall details
- Recalling firm
- Wilson-Cook Medical Inc
- Reason for recall
- There is a possibility that the affected devices would not capture a biopsy during a procedure.
- Action taken
- On April 24, 2002 all field representatives were notified via email and all international accounts via fax. Consignees were advised to quarantine all affected product in their possession and to give the product to their Territory Manager for return. Consignees were urged to complete the bottom portion of the letter and return it via the Territory Manager to Wilson-Cook Medical.
- Root cause
- Other
- Status
- Terminated
- Product code
- FCG
- Quantity affected
- 129 units
- Distribution
- Units were distributed to medical facilities nationwide, UK and Israel
- Date initiated
- 2002-04-23
- Date posted
- 2003-10-31
- Date terminated
- 2003-12-04
- Location
- Winston-Salem, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WILSON-COOK ULTRASOUND BIOPSY NEEDLE (K013356) | Wilson-Cook Medical, Inc. | 2001-10-19 |