Home / Recalls / Progressive Medical Inc / Z-1351-2013

Z-1351-2013 Class II Terminated

Recalled by Progressive Medical Inc — Fenton, MO

Recall Details

Product Type
Devices
Report Date
May 29, 2013
Initiation Date
April 12, 2013
Termination Date
May 7, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
150 boxes with 12 units each.

Product Description

Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Coated Blade 2.50" (6.40) Length, Product number P0012, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries

Reason for Recall

Product coatings require 510K approval.

Distribution Pattern

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.

Code Information

Lot numbers 071212-01, 082712-01 and 111212-04

Other recalls by Progressive Medical Inc

  • Z-1355-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparosco (April 12, 2013)
  • Z-1354-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STIC (April 12, 2013)
  • Z-1348-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STIC (April 12, 2013)
  • Z-1360-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparos (April 12, 2013)
  • Z-1356-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-STICK (April 12, 2013)
  • Z-1350-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparosc (April 12, 2013)
  • Z-1361-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STIC (April 12, 2013)
  • Z-1357-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparosc (April 12, 2013)
  • Z-1363-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparosc (April 12, 2013)
  • Z-1353-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparosc (April 12, 2013)