Recall Z-1830-2015 ยท KGY Bag, Intestine
Cook Inc.
LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applicati
| Date | Jun 24, 2015 (initiated May 14, 2015) |
| Status | Terminated |
| Reason | Includes Information not stated in the intended use. |
| Root cause | Labeling Change Control |
| Action | Cook Medical sent an "Recall Communication Updated Instructions for Use" letter dated May 15, 2015, to all affected customers . The letter identified the product the problem and the action needed to be taken by the customer. Cook has requested that customers do the following: The intended use for the device is being modified from "Used to isolate tissue" during, or prior to, surgical removal and/or morcellation to "Used to isolate tissue" during, or prior to, surgical removal. A contraindication being added is as follows: " Not for use with power morcellators. The warnings are being modif |
| Quantity | 123,184 devices were distributed in commerce |
| Distribution | Worldwide Distribution - US (nationwide) including PR and to the states of: AZ, AK, AL, AR, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, MO, ME, MT, NC, ND, NE, NH, NJ, NY, NM, OH,OK,OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY., and to the countries of : |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K910914 | SURGICAL TISSUE POUCH Cook Urological, Inc., Mar 28, 1991 |