Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smoke, particles, and body and casual fluids from the point of surgical activity during surgical procedures that use ESU for cutting and cauterizing.

Reason: During packaging verification testing, a failure occurred due to cuts in the packaging potentially causing a breach in the sterile barrier. Additional testing identified microscopic aluminum metal shavings and foreign particles estimated in size to be between 0.01inches x 0.015 inches to 0.03 inches x 0.04 inches that were introduced during the manufacturing process and were sterilized within the

Code information: Part Number 0702-045-027

Distribution pattern: Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV,and WY, and the countries of Austria, Canada, Sweden, England, UAE, Netherlands, Spain, and Hong Kong.