The Recall Desk

FDA (Devices) recall action 63530

Quasar Bio-Tech, Inc. dba Silver Bay LLC recalled 3 products on 2012-12-19

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2012-12-19
Critical
0
Units
23,202

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2012-12-19

    Quasar Bio-Tech Recalls Unapproved Infrared LED Lamps and Accessories

    Quasar Bio-Tech is recalling the Quasar MD and other infrared LED devices because they are unapproved for marketing in the United States.

    Product
    Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful Skin***QUASAR MD INCLUDES***QUASAR MD***USER MANUAL***12 VOLT POWER SUPPLY***1 OZ PURE SILK SERUM***Made in the USA.***Five year warranty***" The product…
    Category
    Distribution
    24 states
  • ModerateFDA (Devices)··2012-12-19

    Quasar Bio-Tech Recalls Unapproved LED Skin Treatment Devices

    Quasar Bio-Tech is recalling specific LED skin treatment devices because they are unapproved by the FDA.

    Product
    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…
    Category
    Distribution
    24 states
  • ModerateFDA (Devices)··2012-12-19

    Quasar Bio-Tech Recalls Unapproved Baby Quasar Infrared LED Lamps

    Quasar Bio-Tech is recalling Baby Quasar and Baby Quasar Pink infrared LED lamps because the devices are unapproved by the FDA.

    Product
    Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are labeled in part: "***BABY QUASAR***FOR YOUTHFUL RADIANT SKIN***Skin Rejuvenating System with Sequepulse***Manufactured by: Silver Bay, LLC; Made in the USA, with highest…
    Category
    Distribution
    24 states