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.
FDA Recall Z-0058-2017 · Posted 2016-10-07
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Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeGCJ
Date Initiated2016-09-09
Date Terminated2017-08-25
Product Quantity160 ea. in total
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.
Firm 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 [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.
Root Cause
Process control
Distribution Pattern
US Distribution to states of: AZ, CA, FL, NY, NC, and TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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