FDA Enforcement
Class II
Terminated
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.
Recall: Z-0058-2017
·
Reported October 19, 2016
Enforcement
- Recall Number
- Z-0058-2017
- Event ID
- 75130
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Teleflex Medical
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 19, 2016
- Initiation Date
- September 9, 2016
- Classification Date
- October 7, 2016
- Termination Date
- August 25, 2017
- Address
- 2917 Weck Dr, N/A, Research Triangle Park, NC, 27709-0186, United States
Description
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.
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 Info
Lot Number 73M1500175
Distribution
US Distribution to states of: AZ, CA, FL, NY, NC, and TX.
Quantity
160 ea. in total