| Class 2 Device Recall Progressive Medical NonStick Cautery Tip PTFE Modified Coated Needle | |
Date Initiated by Firm | April 12, 2013 |
Date Posted | May 22, 2013 |
Recall Status1 |
Terminated 3 on May 07, 2014 |
Recall Number | Z-1348-2013 |
Recall Event ID |
64931 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product | Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Needle 2.75" (6.99cm) Length, Product number P0013M, Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128.
Electrodes used in Electrosurgeries |
Code Information |
Lot number 071212-02 |
Recalling Firm/ Manufacturer |
Progressive Medical Inc 997 Horan Dr Fenton MO 63026-2401
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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 | 28 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 |
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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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