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Terminated

Gebauer''s Spray and Stretch Fine- Stream Topical Anesthetic Skin Refrigerant -is intended for topical application to skin for use in controlling pain associated with injections and the temporary relief of minor sporsts injuries. Rx only- 3.5 fl. oz. (103.5ml) can-Product Number 0386-0004-04

FDA Recall Z-1058-2007 · Posted 2007-07-23

Recalling FirmGebauer Company
Recall StatusTerminated
Product CodeMLY
Date Initiated2007-04-17
Date Terminated2009-11-30
Product Quantity21,855 cans of product

Reason for Recall

Mold contamination

Firm Action

The firm sent a recall letter dated April 17, 2007 to all customers.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031036GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03Gebauer Co. · 2003-07-10

Official Source

View FDA Recall →

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

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