Recall Z-0058-2017 ยท GCJ Laparoscope, General & Plastic Surgery
Teleflex Medical
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.
| Date | Oct 7, 2016 (initiated Sep 9, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | 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 recalls@teleflex.com 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 a |
| Quantity | 160 ea. in total |
| Distribution | US Distribution to states of: AZ, CA, FL, NY, NC, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143299 | Percuvance(R) Percutaneous Surgical System Teleflexmedical, Inc., Jan 21, 2015 |