Recall Z-0215-05 ยท GEH Unit, Cryosurgical, Accessories
Premier Dental Products Co
Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical Intrstrument
| Date | Nov 20, 2004 (initiated Apr 29, 2004) |
| Status | Terminated |
| Reason | Cryogen can escape from canister through the seal ring |
| Root cause | Other |
| Action | The recalling firm issued letters to their customers informing them of an enhancement available for the product. The letters are not dated but were issued between 5/02 and 3/04 |
| Quantity | 1060 units |
| Distribution | The product was shipped to distributors and physicians nationwide. The product was shipped to government accounts in CA, DC, FL, LA, MD, MT, NY, SD, TX. The product was also sold in Iceland, Taiwan, Korea, Mexico, Spain, Columbia, Thailand, Singapore, South Africa, Canada, Costa Rica, Panama, Venez |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970992 | PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS Premier Dental Products Co., Jun 17, 1997 |