Z-0519-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 19, 2012
- Initiation Date
- October 25, 2012
- Termination Date
- May 21, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,734 devices total (included in batches identified for the Baby Quasar )
Product Description
Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby Blue uses blue LED light to be used in combination with the Baby Quasar to treat acne. The Quasar Power Pack is labeled in part: "***BABY QUASAR & BABY BLUE***QUASAR POWERPACK***FOR YOUTHFUL, RADIANT, CLEAR SKIN***SKIN REJUVENATING SYSTEM WITH SEQUEPULSE PLUS ADVANCED ACNE CLARIFYING SYSTEM***Manufactured by: Quasar Biotech, Inc., BPP101 LAB-003-E, ***Made in the USA with highest quality components and durable aluminum. Five Year Warranty.***"
Reason for Recall
Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved.
Distribution Pattern
Worldwide distribution: USA (nationwide) including states of: AZ, CA, CO, FL, GA, HI, ID, IL, KS, MD, MI, MN, MO, NC, NJ, NY, NV, OH, OR, TN, TX, UT, VA, and WA; and countries of: Aruba, Canada, Cayman Islands, China, Estonia, Ireland, Malaysia, New Zealand, Singapore, Sweden, Taiwan, and United Kingdom.
Code Information
Quasar Power Pack- Model BPP-101 UPC Code 837654050170, Batch # 11253, 11523, 11658, 2382, 13009, 13177, 13186, 13243, 13270, 13306, 13327, 13342, 13459, 13528, 13529, 13635, 13730, 13767.