Recall Z-0068-04 ยท GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Wilson-Cook Medical Inc
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.
| Date | Oct 24, 2003 (initiated Aug 28, 2002) |
| Status | Terminated |
| Reason | The product was labeled with a 5 year expiration date instead of a 1 year expiration date. |
| 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 | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953951 | WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR Wilson-Cook Medical, Inc., Sep 19, 1995 |