Teleflex Medical recalls Percuvance Johans Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to…

Recall date

July 19, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3221-2017

FDA classification

Class II

Brand / firm

Teleflex Medical

Sold / distributed

Worldwide Distribution - US including AL, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV Internationally to United Arab Emirates, Vienna, Australia, Belgium, Switzerland, China, Germany, Czech Republic, Spain, Finland, France, Unit…

Why it was recalled

For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. For certain other recalled lots of the products, the jaws of the tool tips may close abruptly.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Percuvance Johans Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.