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
- Recall Number
- Z-0058-2017
- Event Number
- 75130
- Firm
- Teleflex Medical
- FEI Number
- 3005747797
- Product Code
- GCJ
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- September 9, 2016
- Posted
- October 7, 2016
- Terminated
- August 25, 2017
- Address
- 2917 Weck Dr, Research Triangle Park, NC, 27709-0186
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.
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.
The firm, Teleflex Medical, sent an "Urgent Medical Device Recall Notification" Letter dated 9/9/2016 to consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any products listed; to return product- complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected] even if you do not have the affected product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
US Distribution to states of: AZ, CA, FL, NY, NC, and TX.
160 ea. in total