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U.S. Department of Health and Human Services

Class 2 Device Recall Gebauer's Topical anesthetic skin refrigerant

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  Class 2 Device Recall Gebauer's Topical anesthetic skin refrigerant see related information
Date Initiated by Firm April 17, 2007
Date Posted July 23, 2007
Recall Status1 Terminated 3 on November 30, 2009
Recall Number Z-1057-2007
Recall Event ID 37778
510(K)Number K032671  
Product Classification Topical anesthetic skin refrigerant - Product Code MLY
Product Gebauer''s Pain Ease Mist Spray- 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 0386-0008-02)
Code Information Lot numbers 4256 expires 08-08; 4257 expires 10-08 and 4258 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 2		 Other
Action The firm sent a recall letter dated April 17, 2007 to all customers.
Quantity in Commerce 6,681 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 and Original Applicant = GEBAUER CO.
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