Recall Z-1058-2007 ยท MLY Vapocoolant Device
Gebauer Company
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
| Date | Jul 23, 2007 (initiated Apr 17, 2007) |
| Status | Terminated |
| Reason | Mold contamination |
| Root cause | Other |
| Action | The firm sent a recall letter dated April 17, 2007 to all customers. |
| Quantity | 21,855 cans of product |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031036 | GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03 Gebauer Co., Jul 10, 2003 |