Z-0517-2013Class II

Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are...

Name: Z-0517-2013 Baby Quasar (LAB-001-D, BQ101) and Baby Quasar Pink (LAB-046-A BQ101-P) are infrared LED lamps that are...
Creator: Quasar Bio-Tech, Inc. dba Silver Bay LLC
Published: 2012-10-25
License: https://open.fda.gov/license/

Quasar Bio-Tech Inc / initiated 2012-10-25 / Terminated

FDA source

Quasar Bio-Tech, Inc. dba Silver Bay LLC began a recall of 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... on 2012-10-25. FDA classified it as Class II and gives the reason as "Quasar Bio-Tech is recalling their Baby Quasar, Baby Quasar Pink, Quasar Power Pack, and Quasar MD because the device is unapproved". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0517-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-25
Posted: 2012-12-12
Terminated: 2013-05-21
Recalling firm: Quasar Bio-Tech Inc
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 quality components and durable aluminum. Five Year Warranty The product emits energy in the near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
Product code: ILY Lamp, Infrared, Therapeutic Heating
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.
FDA root cause: No Marketing Application
Action: The firm, Quasar Bio-Tech, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated November 16, 2012 to its customers. All domestic customers were notified by Certified mail. The letter described the product, problem and actions to be taken. The customers were instructed to cease distribution and remove the products from sale; to complete and return the enclosed Response Form via e-mail to [email protected] or fax to: Quasar Bio-Tech, Attn: Quality/Recall Coordinator: at 941-306-5816, and return all remaining stock to Quasar Bio-Tech at Quasar Bio-Tech Inc., Attn: Quality/Recall Coordinator, 1431 Tallevast Road, Sarasota FL 34243. If you have any questions, contact the Quality/Recall Coordinator at 941-306-5812, Monday-Friday from 9:00 am to 5:00 pm Eastern Standard time.
Quantity in commerce: 7,734 devices total
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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0517-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0517-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-12
Z-0518-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-12
Z-0519-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-19	2012-12-12

Product code ILY

K051046Class IIPainacea Model Xr8 Infrared Heat LampAtlantis Luminescent Products, LLC / cleared 2005-05-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)