Z-2428-2010

Safen' simple Ostomy Appliance Deodorant (8 oz , 1 oz package sizes)

Name: Z-2428-2010 Safen' simple Ostomy Appliance Deodorant (8 oz , 1 oz package sizes)
Creator: BioMed Laboratories
Published: 2010-08-16
License: https://open.fda.gov/license/

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

FDA source

BioMed Laboratories began a recall of Safen' simple Ostomy Appliance Deodorant (8 oz , 1 oz package sizes) on 2010-08-16. The reason FDA records is "The product may contain the mold Aspergillus ssp". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2428-2010
Status: Terminated
Initiated: 2010-08-16
Posted: 2010-09-17
Terminated: 2011-01-24
Recalling firm: Biomed Laboratories LLC
Product: Safen' simple Ostomy Appliance 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: 22,253 (18,060 8oz bottles. 4,193 1oz bottles)
Distribution: OH, FL, MI
Product codes and lots: Safe n Simple (SnS) Ostomy Appliance Deodorant, 8 oz Part # SNS40208, UPS Code 40208 Lots H09001, N09011, N09015, M09020, N09016. Safe n Simple (SnS) Ostomy Appliance Deodorant, 1 oz Lots H09001.

Product code GDS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)