Class 2 Device Recall Gebauer"s Topical anesthetic skin refrigerant

• Date Initiated by Firm: April 17, 2007
• Date Posted: July 23, 2007
• Recall Status: Terminated on November 30, 2009
• Recall Number: Z-1061-2007
• Recall Event ID: 37778
• 510(K)Number: K032671
• Product Classification: Topical anesthetic skin refrigerant - Product Code MLY
• Product: Gebauer''s Pain Ease Medium Stream -Topical Anesthetic Skin Refrigerant is a vapocoolant (skin refrigerant) packed in an aerosol container. Rx only. 103.5ml (3.5 fl. oz.) can-(Product Number-0386-0008-03)
• Code Information: Lot numbers 6257 expires 08-08; 6258 expires 09-08 and 6259 expires 10/08; 6260 expires 11-08 and 6261 expires 12/08
• FEI Number: 1519179
• Recalling Firm/ Manufacturer: Gebauer Company; 4444 E 153rd St; Cleveland OH 44128
• For Additional Information Contact: Amy J Paukovits; 216-581-3030 Ext. 120
• Manufacturer Reason for Recall: Mold contamination
• FDA Determined Cause: Other
• Action: The firm sent a recall letter dated April 17, 2007 to all customers.
• Quantity in Commerce: 9,732 cans of product
• Distribution: Nationwide
• 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.

• 510(K) Database: 510(K)s with Product Code = MLY