BEUDAMED
    FDA Enforcement Class II Terminated

    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.***"

    Recall: Z-0519-2013 · Reported December 19, 2012

    Enforcement

    Recall Number
    Z-0519-2013
    Event ID
    63530
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Quasar Bio-Tech, Inc. dba Silver Bay LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 19, 2012
    Initiation Date
    October 25, 2012
    Classification Date
    December 12, 2012
    Termination Date
    May 21, 2013
    Address
    1431 Tallevast Rd, N/A, Sarasota, FL, 34243-5035, United States

    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

    Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved.

    Code Info

    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.

    Distribution

    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.

    Quantity

    7,734 devices total (included in batches identified for the Baby Quasar )