Gebauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The product consi
FDA device recall Z-0218-2009 · posted 2008-11-12 · Terminated
Recall details
- Recalling firm
- Gebauer Company
- 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.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- MLY
- Quantity affected
- 12,717 Units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-09-03
- Date posted
- 2008-11-12
- Date terminated
- 2010-10-13
- Location
- Cleveland, OH
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 (K002596) | Gebauer Co. | 2001-02-15 |