Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity. Cryosurgical Instrument
FDA device recall Z-0216-05 · posted 2004-11-20 · Terminated
Recall details
- Recalling firm
- Premier Dental Products Co
- Reason for recall
- Cryogen can escape from canister through the seal ring
- Action taken
- 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
- Root cause
- Other
- Status
- Terminated
- Product code
- GEH
- Quantity affected
- 952 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, K
- Date initiated
- 2004-04-29
- Date posted
- 2004-11-20
- Date terminated
- 2006-06-07
- Location
- Plymouth Meeting, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUS (K970992) | Premier Dental Products Co. | 1997-06-17 |