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Teleflex Medical recalls Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park,
Recalled October 19, 2016 · FDA recall Z-0058-2017 · Teleflex Medical
Hazard
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. · FDA Class II
Units
160 ea. in total
Sold at
US Distribution to states of: AZ, CA, FL, NY, NC, and TX.
Description
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.
Product
Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, 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.
Manufacturer(s)
Teleflex Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →