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-1058-2007
• Recall Event ID: 37778
• 510(K)Number: K031036
• Product Classification: Topical anesthetic skin refrigerant - Product Code MLY
• Product: Gebauer''s Spray and Stretch Fine- Stream Topical Anesthetic Skin Refrigerant -is intended for topical application to skin for use in controlling pain associated with injections and the temporary relief of minor sporsts injuries. Rx only- 3.5 fl. oz. (103.5ml) can-Product Number 0386-0004-04
• Code Information: Lot Numbers: 8019 expires 08-08; 8020 expires 09-08; 8021 expires 10-08 and 8022 expires 12/08
• 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: 21,855 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