Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity. Cryosurgical Instrument
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-0216-05
- Quantity
- 952 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 LP-10000 through LP-10951
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
More recalls by Premier Dental Products Co
Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical Intrstrument
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Laryngectomy Tubes, Air Lon Nylon, item number1050170 size 8 and item number 1050172 size 10.
Sep 15, 2004