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FDA (Device enforcement)Recalled 2012-10-25closedclass ii

Quasar Bio-Tech, Inc. dba Silver Bay LLC: 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 RADIAN

Is my product affected?

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 quality components and dur

  • UPC 89076290272
  • UPC 837654072172

Check against the official notice below — it lists the full affected range.

What happened

Quasar Bio-Tech, Inc. is recalling 7,734 Baby Quasar and Baby Quasar Pink infrared LED lamps, along with Quasar Power Pack and Quasar MD devices, because the devices are unapproved. The affected products were distributed worldwide, including throughout the United States and multiple countries such as Canada, the United Kingdom, China, and others.

The recall affects specific model numbers and batch codes. Baby Quasar (Model BQ-101) devices have UPC Code 6 89076290272 and include multiple batch numbers ranging from 11253 to 13767. Baby Quasar Pink (Model BQ-101-P) devices have UPC 837654072172 and include batch numbers 11927, 11945, 11989, 11990, 12017, and 12073. The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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: 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 Lot/code info: Baby Quasar- Model BQ-101, UPC Code 6 89076290272, Batch # 11253, 11523, 11658, 2382, 13009, 13177, 13186, 13243, 13270, 13306, 13327, 13342, 13459, 13528, 13529, 13635, 13730, 13767. Baby Quasar Pink- Model BQ-101-P, UPC 837654072172, Batch # 11927, 11945, 11989, 11990 12017,12073.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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