RecallDepth

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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