Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparoscopic Electrode PTFE Coated Curved Blade 3

FDA device recall Z-1355-2013 · posted 2013-05-22 · Terminated

Recall details

Recalling firm

Progressive Medical Inc

Reason for recall

Product coatings require 510K approval.

Action taken

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.

Root cause

Manufacturing material removal

Status

Terminated

Product code

GEI

Quantity affected

38 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.

Date initiated

2013-04-12

Date posted

2013-05-22

Date terminated

2014-05-07

Location

Fenton, MO