Recall Z-0079-04 ยท FCG Biopsy Needle
Wilson-Cook Medical Inc
EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR. Tapered to 4.5FR. Length: 138-140 CM. Adjustable Needle: 19 GA. Needle Extension: 0-8 CM. Adjustable Minimum Endoscope Channel: 2.0 MM. Disposable-Single Use Only Sterile Shelf Life: 5 Years, Wilson Cook Medical GI Endoscopy, 4900 Bethania Station Road, Winston Salem, NC 27105.
| Date | Oct 31, 2003 (initiated Apr 23, 2002) |
| Status | Terminated |
| Reason | There is a possibility that the affected devices would not capture a biopsy during a procedure. |
| Root cause | Other |
| Action | 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. |
| Quantity | 129 units |
| Distribution | Units were distributed to medical facilities nationwide, UK and Israel |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013356 | WILSON-COOK ULTRASOUND BIOPSY NEEDLE Wilson-Cook Medical, Inc., Oct 19, 2001 |