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.
This recall has been terminated (originally issued October 31, 2003).
- Company
- Wilson-Cook Medical Inc
- Recall Initiated
- April 23, 2002
- Posted
- October 31, 2003
- Terminated
- December 4, 2003
- Recall Number
- Z-0079-04
- Quantity
- 129 units
- Firm Location
- Winston-Salem, NC
- Official Source
- View on FDA website ↗
Reason for Recall
There is a possibility that the affected devices would not capture a biopsy during a procedure.
Distribution
Units were distributed to medical facilities nationwide, UK and Israel
Lot / Code Info
Lot #1580452, 1583962, 1584813, 1586227, 1587259, 1588313, 1589076, 1590011, 1591358, 1594584 (under hold in finished goods), and 1592359.
Root Cause
Other
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.