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.
This recall has been terminated (originally issued October 7, 2016).
- Company
- Teleflex Medical
- Recall Initiated
- September 9, 2016
- Posted
- October 7, 2016
- Terminated
- August 25, 2017
- Recall Number
- Z-0059-2017
- Quantity
- 160 ea. in total
- Firm Location
- Research Triangle Park, NC
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Distribution to states of: AZ, CA, FL, NY, NC, and TX.
Lot / Code Info
Lot Number 73M1500176
Root Cause
Process control
Action Taken
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 at 1-866-246-6990.