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U.S. Department of Health and Human Services

Class 2 Device Recall Progressive Medical NONSTICK CAUTERY TIP PTFE Coated Blade

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  Class 2 Device Recall Progressive Medical NONSTICK CAUTERY TIP PTFE Coated Blade see related information
Date Initiated by Firm April 12, 2013
Date Posted May 22, 2013
Recall Status1 Terminated 3 on May 07, 2014
Recall Number Z-1351-2013
Recall Event ID 64931
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product 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
Code Information Lot numbers 071212-01, 082712-01 and 111212-04
Recalling Firm/
Manufacturer		 Progressive Medical Inc
997 Horan Dr
Fenton MO 63026-2401
For Additional Information Contact Glenda Krueger
800-969-6331
Manufacturer Reason
for Recall		 Product coatings require 510K approval.
FDA Determined
Cause 2		 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 150 boxes with 12 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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