Z-0059-2017Class II

Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured for: Teleflex...

Name: Z-0059-2017 Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured for: Teleflex...
Creator: Teleflex Medical
Published: 2016-09-09
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2016-09-09 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709 The Percutaneous Surgical... on 2016-09-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0059-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-09
Posted: 2016-10-07
Terminated: 2017-08-25
Recalling firm: Teleflex Medical
Product: 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.
Product code: GCJ Laparoscope, General & Plastic Surgery
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.
Root cause tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 160 ea. in total
Distribution: US Distribution to states of: AZ, CA, FL, NY, NC, and TX.
Product codes and lots: Lot Number 73M1500176

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0059-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0058-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-07
Z-0059-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-07

Product code GCJ

K143299Class IIPercuvance(R) Percutaneous Surgical SystemTeleflexmedical, Inc. / cleared 2015-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)