Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical Intrstrument
This recall has been terminated (originally issued November 20, 2004).
- Company
- Premier Dental Products Co
- Recall Initiated
- April 29, 2004
- Posted
- November 20, 2004
- Terminated
- June 7, 2006
- Recall Number
- Z-0215-05
- Quantity
- 1060 units
- Firm Location
- Plymouth Meeting, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Cryogen can escape from canister through the seal ring
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, Venezuela, and United Kingdom.
Lot / Code Info
Serial numbers RP-10000 through RP-11060
Root Cause
Other
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
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