Fusion OMNI ERCP Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
FDA device recall Z-0160-2007 · posted 2006-11-08 · Terminated
Recall details
- Recalling firm
- Cook Endoscopy
- Reason for recall
- Injection through the flush port of these ERCP catheters may be compromised due to omission of a manufacturing activity.
- Action taken
- Cook Ireland customers were notified by letter via email on 10/13/2006.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KOG
- Quantity affected
- 20 units
- Distribution
- Worldwide.
- Date initiated
- 2006-10-05
- Date posted
- 2006-11-08
- Date terminated
- 2006-12-15
- Location
- Winston Salem, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ERCP CATHETER, HYDROPHILIC COATED (K932205) | Wilson-Cook Medical, Inc. | 1994-01-03 |