Z-0216-05

Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity. Cryosurgical Instrument

Name: Z-0216-05 Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity. Cryosurgical Instrument
Creator: Premier Dental Products Co
Published: 2004-04-29
License: https://open.fda.gov/license/

Premier Dental Products Co / initiated 2004-04-29 / Terminated

FDA source

Premier Dental Products Co began a recall of Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity. Cryosurgical Instrument on 2004-04-29. The reason FDA records is "Cryogen can escape from canister through the seal ring". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0216-05
Status: Terminated
Initiated: 2004-04-29
Posted: 2004-11-20
Terminated: 2006-06-07
Recalling firm: Premier Dental Products Co
Product: Nitrospray Plus Lite (Item #1006065) with a 10 ounce fill capacity. Cryosurgical Instrument
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: Cryogen can escape from canister through the seal ring
FDA root 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: 952 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.
Product codes and lots: Serial numbers LP-10000 through LP-10951

Product code GEH

K970992Class IIPremier Nitrospray Plus and Premier Nitrospray Lite PlusPremier Dental Products Co. / cleared 1997-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)