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Terminated

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 applications in the Urology, Surgery, and Reproductive Health business units.

FDA Recall Z-1830-2015 · Posted 2015-06-24

Recalling FirmCook Inc.
Recall StatusTerminated
Product CodeKGY
Date Initiated2015-05-14
Date Terminated2016-09-12
Product Quantity123,184 devices were distributed in commerce

Reason for Recall

Includes Information not stated in the intended use.

Firm 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 modified to read as follows: " The LapSac Surgical Tissue Pouch is not intended for use with sharp surgical instruments. " Care should be taken to avoid damaging, puncturing or tearing the LapSac Surgical Tissue Pouch. " Use caution when removing potentially malignant or harmful tissues, to isolate contamination from surrounding tissue. The instructions for use are being modified to read as follows: 1. Following aseptic technique, introduce the LapSac Surgical Tissue Pouch into the abdominal cavity. 2. Place tissue to be removed from the body into the pouch. 3. Using the drawstring, carefully close the LapSac Surgical Tissue Pouch. Please note that if excess force is used, the drawstring may break or tear the LapSac. 4. Remove the LapSac Surgical Tissue Pouch from the body, taking care not to spill contents of the bag. Please report any Adverse Event to Cook Medical Customer Relations (800) 457-4500 or 1-812-339-2235. Monday through Friday between 7:30 a.m. and 5:00 p.m. Eastern Daylight Time or email at [email protected]; and to FDA. The customer notice must be passed on to appropriate personnel within each organization or to any organization where the potentially affected devices have been transferred. If customers have further questions regarding labelling changes for this device, please contact Cook Sales Representative or Cook M

Root Cause

Labeling Change Control

Distribution Pattern

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 : China, Korea, Denmark, Mexico, New Zealand, India and Colombia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K910914SURGICAL TISSUE POUCHCook Urological, Inc. · 1991-03-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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