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Terminated

Nitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical Intrstrument

FDA Recall Z-0215-05 · Posted 2004-11-20

Recalling FirmPremier Dental Products Co
Recall StatusTerminated
Product CodeGEH
Date Initiated2004-04-29
Date Terminated2006-06-07
Product Quantity1060 units

Reason for Recall

Cryogen can escape from canister through the seal ring

Firm 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

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970992PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUSPremier Dental Products Co. · 1997-06-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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