Device product
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.
Z-0059-2017
Product summary
- Firm
- Teleflex Medical
- Event
- Event 75130
- Status
- Terminated
- Classification
- Class II
- Quantity
- 160 ea. in total
- Official record key
device-enforcement:Z-0059-2017
Official wording
Reason: 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.
Code information: Lot Number 73M1500176
Distribution pattern: US Distribution to states of: AZ, CA, FL, NY, NC, and TX.
Derived failure modes
-
Labeling or packaging
labeling error