17,428 Fraxel Skin Ecology masks, 3 types: mold & yeast contamination

[notyard]

U.S. FDA class II recall:

PRODUCT
a) Fraxel Green Tea Infusion Mask maintenance, by Fraxel Skin Ecology System,
in cardboard box, 3 masks per box Part number 09-03730, Recall # F-503-8;
b) Fraxel Deep Hydration Mask post treatment, by Fraxel Skin Ecology System,
in cardboard box, 3 masks per box Part number 09-03772, Recall # F-504-8;
c) Fraxel Deep Hydration Mask post treatment, by Fraxel Skin Ecology System,
in cardboard box, 10 masks per box Part number 09-03721, Recall # F-505-8
CODE
All product shipped before 04/09/2008, with an expiration date of September 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Reliant Technologies Inc., Mountain View, CA, by telephone and letter beginning May 22, 2008.
Manufacturer: Dicon Technologies Llc, Allendale, NJ. Firm initiated recall is ongoing.
REASON
a) Products may be contaminated with Penicillium spp., and Mucor spp;
b) and c) Products may be contaminated with Penicillium spp., Candida sp., and Cladosporium spp.
VOLUME OF PRODUCT IN COMMERCE
17,428 masks
DISTRIBUTION
Nationwide