ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew Right Device: Flexible TI Knot Device: External Accessory C
FDA device recall Z-0698-05 · posted 2005-04-08 · Terminated
Recall details
- Recalling firm
- Wilson-Cook Medical Inc
- Reason for recall
- The expiration date listed on the product label is greater than the vendor recommended expiration date.
- Action taken
- Consignees were notified by certified mail on 04/01/2005.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 167 units
- Distribution
- Nationwide, Brazil, Canada, Hong Kong, Ireland & Pakistan
- Date initiated
- 2005-04-01
- Date posted
- 2005-04-08
- Date terminated
- 2005-07-08
- 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 |
|---|---|---|
| LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT (K011016) | Lsi Solutions | 2001-04-27 |