Medical Device
Manufacturing
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Z-1060-2007

Gebauer''s Instant Ice Medium Stream - temporary relief and reduction of minor pain and swelling from...

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

Gebauer Company began a recall of Gebauer''s Instant Ice Medium Stream - temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports... on . The reason FDA records is "Mold contamination". As of , the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number
Z-1060-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Gebauer Co
Product
Gebauer''s Instant Ice Medium Stream - temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries.-3.5 fl. oz. (103.5ml) can-(Product Number-0386-0010-01)
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
905 cans of product
Distribution
Nationwide
Product codes and lots
Lot numbers 6015 expires 10-08 and 6016 expires 11/08