Z-1352-2013Class II

Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated...

Name: Z-1352-2013 Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated...
Creator: Progressive Medical Inc
Published: 2013-04-12
License: https://open.fda.gov/license/

Progressive Medical Inc / initiated 2013-04-12 / Terminated / root cause: manufacturing process

FDA source

Progressive Medical Inc began a recall of Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 33cm Length, Product number P0100 Rx... on 2013-04-12. FDA classified it as Class II and gives the reason as "Product coatings require 510K approval". 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-1352-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-12
Posted: 2013-05-22
Terminated: 2014-05-07
Recalling firm: Progressive Medical Inc
Product: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparoscopic Electrode PTFE Coated Wire L Hook 33cm Length, Product number P0100 Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Product coatings require 510K approval.
Root cause tag: manufacturing process
FDA root cause: Manufacturing material removal
Action: Progressive Medical Inc. sent an Urgent Medical Device Recall letter dated April 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and segregate the affected units prior to return to Progressive Medical, Inc. If product was further distributed customers should notify their accounts of ther ecall and return the products. Customers were asked to complete and return the attached form by fax to 314-961-4535, even if they had no inventory remaining. Customers with questions were instructed to call 1-800-969-6331. For questions regarding this recall call 314-961-5786.
Quantity in commerce: 59 boxes with 6 units each.
Distribution: Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.
Product codes and lots: Lot numbers 071212-06 and 082712-13

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1352-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1348-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22
Z-1349-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22
Z-1350-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22
Z-1351-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22
Z-1352-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22
Z-1353-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22
Z-1354-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22
Z-1355-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22
Z-1356-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22
Z-1357-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22
Z-1358-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22
Z-1359-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22
Z-1360-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22
Z-1361-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22
Z-1362-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22
Z-1363-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22
Z-1364-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-22

Product code GEI

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)