Quantum TTC Biliary Balloon Dilator
FDA device recall Z-1292-03 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Wilson-Cook Medical Inc
- Reason for recall
- The product was labeled 'esophageal', but contained a 'biliary' ballon
- Action taken
- The consignees were notified of the recall via letter on September 15, 2003. The bottom portion of the recall communication is to be returned indicating amount of product being returned or indicating no product was to be returned.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNQ
- Quantity affected
- 127 devices
- Distribution
- Nationwide. CA, FL, IL, IN, IA, KS, LA, MI, MO, NJ, NC, OH, OK, TX, VA, WA, WI and foreign accounts in Canada, England, India, Japan, Korea, Mexico and Uruguary,
- Date initiated
- 2003-09-15
- Date posted
- 2003-10-15
- Date terminated
- 2004-04-08
- Location
- Winston-Salem, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BALLOON DILATION CATHETER (K935094) | Wilson-Cook Medical, Inc. | 1995-01-24 |