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Terminated

Gebauer''s Pain Ease Medium Stream -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-0386-0008-03)

FDA Recall Z-1061-2007 · Posted 2007-07-23

Recalling FirmGebauer Company
Recall StatusTerminated
Product CodeMLY
Date Initiated2007-04-17
Date Terminated2009-11-30
Product Quantity9,732 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.

K032671GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07Gebauer Co. · 2004-03-17

Official Source

View FDA Recall →

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

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