Z-1057-2007

Gebauer''s Pain Ease Mist Spray- Topical Anesthetic Skin Refrigerant -is a vapocoolant (skin refrigerant)...

Name: Z-1057-2007 Gebauer''s Pain Ease Mist Spray- Topical Anesthetic Skin Refrigerant -is a vapocoolant (skin refrigerant)...
Creator: Gebauer Company
Published: 2007-04-17
License: https://open.fda.gov/license/

Gebauer Co / initiated 2007-04-17 / Terminated / root cause: sterility

FDA source

Gebauer Company began a recall of Gebauer''s Pain Ease Mist Spray- Topical Anesthetic Skin Refrigerant -is a vapocoolant (skin refrigerant) packed in an aerosol container. Rx only-103.5ml (3.5... on 2007-04-17. The reason FDA records is "Mold contamination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1057-2007
Status: Terminated
Initiated: 2007-04-17
Posted: 2007-07-23
Terminated: 2009-11-30
Recalling firm: Gebauer Co
Product: Gebauer''s Pain Ease Mist Spray- Topical Anesthetic Skin Refrigerant -is a vapocoolant (skin refrigerant) packed in an aerosol container. Rx only-103.5ml (3.5 fl. oz.) can. Product Number 0386-0008-02)
Product code: MLY Vapocoolant Device
Reason for recall: Mold contamination
Root cause tag: sterility
FDA root cause: Other
Action: The firm sent a recall letter dated April 17, 2007 to all customers.
Quantity in commerce: 6,681 cans of product
Distribution: Nationwide
Product codes and lots: Lot numbers 4256 expires 08-08; 4257 expires 10-08 and 4258 expires 12/08

Product code MLY

K032671UnclassifiedGebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray), Models P/n 0386-0010-07Gebauer Co. / cleared 2004-03-17

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)