Recall Z-2426-2010 ยท GDS Bag, Stomal
BioMed Laboratories
Reliamed Odor Eliminator Drops (8 oz, 4 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 | 33,772 Units (27,148 8oz bottles. 3,492 4oz bottles. 3,132 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.