Class 2 Device Recall FluroEthyl.

• Date Initiated by Firm: September 03, 2008
• Date Posted: November 12, 2008
• Recall Status: Terminated on October 13, 2010
• Recall Number: Z-0218-2009
• Recall Event ID: 49463
• 510(K)Number: K002596
• Product Classification: Topical (vapocoolant) refrigerant. - Product Code MLY
• Product: Gebauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The product consists of a can, a valve and an actuator. Gebauer's Fluro-Ethyl is a vapocoolant (skin refrigerant), topical anesthetic intended to control the pain associated with minor surgical procedures, dermabrasion and injection. It is also effective in providing temporary relief from the pain associated with minor sports injuries.
• Code Information: Model Number: P/N 0386-0002-20. Lot Numbers: 7010, 7011, and 7012.
• 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: Some units of Fluro-Ethyl containing the defective valve which could malfunction and spray refrigerant out from the side of the valve in addition to or instead of spraying in the normal inverted position from the product's actuator. The product can also leak coolant from the side of the valve onto the fingers of the user.
• FDA Determined Cause: Component design/selection
• Action: A recall notification letter (Recall Notice) (dated 9/3/2008) was issued on 9/16/2008 to customers. The notice instructs customers to check their inventory for any remaining recall product and if found, return the product to the Gebauer Company. The letter also advises distributors to notify their customers and follow instructions as noted above, i.e. customers inventory their stock for recalled product and if found, return to the Gauber Company. For questions or additional information, contact Gebauer Company at 216-581-3030 (ext. 120) or 800-321-9348.
• Quantity in Commerce: 12,717 Units
• Distribution: Nationwide Distribution.
• 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