Z-0218-2009

Gebauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The...

Name: Z-0218-2009 Gebauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The...
Creator: Gebauer Company
Published: 2008-09-03
License: https://open.fda.gov/license/

Gebauer Co / initiated 2008-09-03 / Terminated / root cause: design

FDA source

Gebauer Company began a recall of Gebauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The product consists of a can, a valve and an actuator... on 2008-09-03. The reason FDA records is "Some units of Fluro-Ethyl containing the defective valve which could malfunction and spray refrigerant out from the side of the valve in addition to or instead of spraying in the normal inverted position from the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0218-2009
Status: Terminated
Initiated: 2008-09-03
Posted: 2008-11-12
Terminated: 2010-10-13
Recalling firm: Gebauer Co
Product: Gebauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The product consists of a can, a valve and an actuator. Gebauer's Fluro-Ethyl is a vapocoolant (skin refrigerant), topical anesthetic intended to control the pain associated with minor surgical procedures, dermabrasion and injection. It is also effective in providing temporary relief from the pain associated with minor sports injuries.
Product code: MLY Vapocoolant Device
Reason for recall: Some units of Fluro-Ethyl containing the defective valve which could malfunction and spray refrigerant out from the side of the valve in addition to or instead of spraying in the normal inverted position from the product's actuator. The product can also leak coolant from the side of the valve onto the fingers of the user.
Root cause tag: design
FDA root cause: Component design/selection
Action: A recall notification letter (Recall Notice) (dated 9/3/2008) was issued on 9/16/2008 to customers. The notice instructs customers to check their inventory for any remaining recall product and if found, return the product to the Gebauer Company. The letter also advises distributors to notify their customers and follow instructions as noted above, i.e. customers inventory their stock for recalled product and if found, return to the Gauber Company. For questions or additional information, contact Gebauer Company at 216-581-3030 (ext. 120) or 800-321-9348.
Quantity in commerce: 12,717 Units
Distribution: Nationwide Distribution.
Product codes and lots: Model Number: P/N 0386-0002-20. Lot Numbers: 7010, 7011, and 7012.

Product code MLY

K002596UnclassifiedGebauer's Fluro Ethyl, Model 0386-0002-09Gebauer Co. / cleared 2001-02-15

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)