Z-0079-04

EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR. Tapered to 4.5FR...

Name: Z-0079-04 EUSN-19-QC Quick-Core Ultrasound Biopsy Needle, Specimen Notch: 20 MM.; Diameter: 5.2 FR. Tapered to 4.5FR...
Creator: Wilson-Cook Medical Inc
Published: 2002-04-23
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2002-04-23 / Terminated

FDA source

Wilson-Cook Medical Inc began a recall of 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... on 2002-04-23. The reason FDA records is "There is a possibility that the affected devices would not capture a biopsy during a procedure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0079-04
Status: Terminated
Initiated: 2002-04-23
Posted: 2003-10-31
Terminated: 2003-12-04
Recalling firm: Wilson-Cook Medical Inc.
Product: 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.
Product code: FCG Biopsy Needle
Reason for recall: There is a possibility that the affected devices would not capture a biopsy during a procedure.
FDA 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 in commerce: 129 units
Distribution: Units were distributed to medical facilities nationwide, UK and Israel
Product codes and lots: Lot #1580452, 1583962, 1584813, 1586227, 1587259, 1588313, 1589076, 1590011, 1591358, 1594584 (under hold in finished goods), and 1592359.

Product code FCG

K013356Class IIWilson-Cook Ultrasound Biopsy NeedleWilson-Cook Medical, Inc. / cleared 2001-10-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)