Teleflex Medical recalls Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park,…

Recall date

September 9, 2016

Source

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

Recall number

Z-0059-2017

FDA classification

Class II

Brand / firm

Teleflex Medical

Sold / distributed

US Distribution to states of: AZ, CA, FL, NY, NC, and TX.

Why it was recalled

The product is being recalled due to a labeling error. The Gripper Graspers are labeled as Johans Graspers and the Johans Graspers are labeled as Gripper Graspers.

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

What was recalled

Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and manipulate tissue during laparoscopic surgery.