Recall Z-0218-2009 ยท MLY Vapocoolant Device
Gebauer Company
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 th
| Date | Nov 12, 2008 (initiated Sep 3, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 12,717 Units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002596 | GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 Gebauer Co., Feb 15, 2001 |