Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2427-2010

Genairex Securi-T Ostomy Deodorant (8 oz, 1 oz package sizes)

Biomed Laboratories LLC / initiated 2010-08-16 / Terminated / root cause: manufacturing process

BioMed Laboratories began a recall of Genairex Securi-T Ostomy Deodorant (8 oz, 1 oz package sizes) on . The reason FDA records is "The product may contain the mold Aspergillus ssp". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2427-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Biomed Laboratories LLC
Product
Genairex Securi-T Ostomy Deodorant (8 oz, 1 oz package sizes)
Product code
GDS Bag, Stomal
Reason for recall
The product may contain the mold Aspergillus ssp.
Root cause tag
manufacturing process
FDA root cause
Material/Component Contamination
Action
Biomed Laboratories, Inc. of Garland, TX is conducting a recall of the Reliamed Odor Eliminator Drops, Securi-T Ostomy Deodorant, and the Safe n' Simple (Sn'S) Ostomy Appliance Deodorant. Lots being recalled were distributed between June 9, 2009 though June 28, 2010. Biomed will work with their 3 consignees to inform sub-distributors and down to any firm that keeps the product in stock to have the product removed from further distribution and returned. If there are any questions or concerns, please contact Biomed Laboratories, Inc. at (972) 282-8008 or email them at biomedlabs.net.
Quantity in commerce
16,234 (15,054 8oz bottles. 1,180 1oz bottles).
Distribution
OH, FL, MI
Product codes and lots
Securi-T Ostomy Deodorant, 8 oz  Part # 108000, UPS Code 81164000810 Lots: E10051