Recall Z-2428-2010 ยท GDS Bag, Stomal
BioMed Laboratories
Safen' simple Ostomy Appliance Deodorant (8 oz , 1 oz package sizes)
| Date | Sep 17, 2010 (initiated Aug 16, 2010) |
| Status | Terminated |
| Reason | The product may contain the mold Aspergillus ssp. |
| 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 | 22,253 (18,060 8oz bottles. 4,193 1oz bottles) |
| Distribution | OH, FL, MI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.