Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year,
FDA device recall Z-0068-04 · posted 2003-10-24 · Terminated
Recall details
- Recalling firm
- Wilson-Cook Medical Inc
- Reason for recall
- The product was labeled with a 5 year expiration date instead of a 1 year expiration date.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- GCA
- Quantity affected
- 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, Ja
- Date initiated
- 2002-08-28
- Date posted
- 2003-10-24
- Date terminated
- 2003-11-25
- Location
- Winston-Salem, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR (K953951) | Wilson-Cook Medical, Inc. | 1995-09-19 |