Recall Z-1057-2007 ยท MLY Vapocoolant Device
Gebauer Company
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)
| 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 | 6,681 cans of product |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032671 | GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07 Gebauer Co., Mar 17, 2004 |