Z-0519-2013Class II

Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby...

Name: Z-0519-2013 Quasar Power Pack contains a Baby Quasar and a Baby Blue. The Baby Quasar is an infrared LED lamp. The Baby...
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 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... 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-0519-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-25
Posted: 2012-12-12
Terminated: 2013-05-21
Recalling firm: Quasar Bio-Tech Inc
Product: 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.***"
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 (included in batches identified for the Baby Quasar )
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: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0519-2013
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)