Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with… recallZ-0068-04 · Wilson-Cook Medical Inc · initiated Aug 28, 2002
Terminated All recalls posted in October 2003
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Wilson-Cook Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The product was labeled with a 5 year expiration date instead of a 1 year expiration date.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0068-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 28, 2002
- Posted by the FDA
- Oct 24, 2003
- Recalling firm
- Wilson-Cook Medical Inc
- Quantity
- 2062 units
- Product code
- GCA
- FDA submissions
- K953951
- 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 description
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.
Code information (models, lots, serial numbers)
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.
Other devices under the same FDA submission
5 devices cleared under K953951 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Tri-Ex G26856Cook Incorporated · CATHETER, BILIARY, SURGICAL4 reports
- Escort II G21603Cook Incorporated · CATHETER, BILIARY, SURGICAL2 reports
- D.A.S.H. G25620Cook Incorporated · CATHETER, BILIARY, SURGICAL2 reports
- Escort II G21664Cook Incorporated · CATHETER, BILIARY, SURGICAL1 report
- Escort II G22262Cook Incorporated · CATHETER, BILIARY, SURGICAL1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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