Recall Z-2691-2011 ยท MND Ligator, Esophageal
Cook Endoscopy
Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal sub-mucosal defects less thank 3cm in the upper GI tract, bleeding ulcers, arteries les than 2 mm, and polyps less than 1.5cm in diameter in the GI tract,. Thi
| Date | Jun 28, 2011 (initiated Jun 7, 2011) |
| Status | Terminated |
| Reason | The disposable clip may not deploy after being positioned inside the patient. |
| Root cause | Device Design |
| Action | Wilson-Cook Medical, Inc. (Cook Endoscopy) sent an "URGENT: PRODUCT RECALL" notice dated June 7, 2011 and a "PRODUCT RECALL EFFECTIVENESS SURVEY' dated June 21, 2011 to all affected consignees. The notice described the product, problem, and actions to be taken. Medical users were instructed to quarantine any affected products and return to Cook Medical. The distributors were instructed to contact their customers and coordinate the return of the affected products to Cook Medical. The recalled notice and survey should be completed and returned to Cook Medical via fax to 812-339-7316 or scan |
| Quantity | 307 units |
| Distribution | (USA) Nationwide Distribution including the states of: CA, HI, MA, ME, NC and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023903 | WILSON-COOK ENDOSCOPIC CLIPPING DEVICE Wilson-Cook Medical, Inc., Feb 20, 2003 |