Recall Z-0698-05 ยท GCJ Laparoscope, General & Plastic Surgery
Wilson-Cook Medical Inc
ESD-5, ESD Flexible Endoscopic Suturing Device, Flexible Sew Right Device: Flexible TI Knot Device: External Accessory Channel: 6mm./75 cm.; * Suture Quickload Units (2); TI Knot Quickload Units (2) * Disposable Single Use Only * Manufactured by: LSI Solutions * Sterile/EO * Rx Only * Wilson-Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
| Date | Apr 8, 2005 (initiated Apr 1, 2005) |
| Status | Terminated |
| Reason | The expiration date listed on the product label is greater than the vendor recommended expiration date. |
| Root cause | Labeling False and Misleading |
| Action | Consignees were notified by certified mail on 04/01/2005. |
| Quantity | 167 units |
| Distribution | Nationwide, Brazil, Canada, Hong Kong, Ireland & Pakistan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011016 | LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT Lsi Solutions, Apr 27, 2001 |