Z-0068-04

Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf...

Name: Z-0068-04 Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf...
Creator: Wilson-Cook Medical Inc
Published: 2002-08-28
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2002-08-28 / Terminated / root cause: labeling and UDI

FDA source

Wilson-Cook Medical Inc began a recall of Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only... on 2002-08-28. The reason FDA records is "The product was labeled with a 5 year expiration date instead of a 1 year expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0068-04
Status: Terminated
Initiated: 2002-08-28
Posted: 2003-10-24
Terminated: 2003-11-25
Recalling firm: Wilson-Cook Medical Inc.
Product: Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only, Wilson-Cook Medical, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Product code: GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Reason for recall: The product was labeled with a 5 year expiration date instead of a 1 year expiration date.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Field Representatives were notified via Fax or E-mail in August/September, 2002. After being notified about the recall, field representatives were responsible for notifying facilities about the market withdrawal and for furnishing instructions for returning products for credit.
Quantity in commerce: 2062 units
Distribution: Nationwide; Argentina, Australia, Barbados, Bolivia, WI, Brazil, Canada, Costa Rica, Central Hong Kong, Colombia, Ecuador, El Salvador, England, Egypt, Guatemala, India, Indonesia, Ireland, Israel, Japan, Korea, Malaysia, Mexico, New Zealand, Pakistan, Philippines, Peoples Republic of China, Poland, Republic of Panama, Romania, Saudi Arabia, Singapore, Sri Lanka, Syria, Taiwan, Thailand, United Arab Emirates, Venezuela, Uruguay.
Product codes and lots: Lots 1602780, 160281, 1602782, 1602784, 1602785, 1602786, 1602788, 1602789, 1602790, 1602791, 1602792, 1602793, 1602794, 1602795, 1602796, 1602797, 1602798, 1602799, 1602800, 1602801, 1602802, 1607143, 1607144, 1610890, 1611901, 1613669, 1613670, 1614712, 1615429, 1615745, 1617031, 1617649, 1618498, 1620684, 1620928., 1621381, 1621496, 1621691, 1621692, 1622879, 16254321, 1626364, 1626669, 1627928, 1628134, 1629489, 1630384, 1630385, 1633042, 1633043, 1620783, 1623781, 1624348, 1625245, 1627107, 1629245, 1630813, 1634319, 1633787, 1634878, and 1635692.

Product code GCA

K953951Class IIWilson-Cook Triple Lumen Balloon Stone ExtractorWilson-Cook Medical, Inc. / cleared 1995-09-19

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)