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.
FDA Recall Z-0079-04 · Posted 2003-10-31
Recalling FirmWilson-Cook Medical Inc
Recall StatusTerminated
Product CodeFCG
Date Initiated2002-04-23
Date Terminated2003-12-04
Product Quantity129 units
Reason for Recall
There is a possibility that the affected devices would not capture a biopsy during a procedure.
Firm 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.
Root Cause
Other
Distribution Pattern
Units were distributed to medical facilities nationwide, UK and Israel
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.