Class 2 Device Recall Nitrospray Plus

• Date Initiated by Firm: April 29, 2004
• Date Posted: November 20, 2004
• Recall Status: Terminated on June 07, 2006
• Recall Number: Z-0215-05
• Recall Event ID: 30366
• 510(K)Number: K970992
• Product Classification: Unit, Cryosurgical, Accessories - Product Code GEH
• Product: Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical Intrstrument
• Code Information: Serial numbers RP-10000 through RP-11060
• Recalling Firm/ Manufacturer: Premier Dental Products Co; 1710 Romano Dr; Plymouth Meeting PA 19462-2822
• For Additional Information Contact: Vince D'Alessandro; 610-239-6015
• Manufacturer Reason for Recall: Cryogen can escape from canister through the seal ring
• FDA Determined 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 in Commerce: 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, Venezuela, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GEH