Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1059-2007

Gebauer''s Instant Ice Mist- is used like ice for the temporary relief and reduction of minor pain and...

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

Gebauer Company began a recall of Gebauer''s Instant Ice Mist- is used like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or... 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-1059-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Gebauer Co
Product
Gebauer''s Instant Ice Mist- is used like ice for the 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: 0386-0010-05-)
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
502 cans of product
Distribution
Nationwide
Product codes and lots
Lot number 4009 expires 08-08; 4010 expires 12/08