| Class 2 Device Recall Quasar MD | |
Date Initiated by Firm | October 25, 2012 |
Date Posted | December 12, 2012 |
Recall Status1 |
Terminated 3 on May 21, 2013 |
Recall Number | Z-0518-2013 |
Recall Event ID |
63530 |
510(K)Number | K051046 |
Product Classification |
Lamp, infrared, therapeutic heating - Product Code ILY
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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 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. |
Code Information |
Quasar MD- Model QMD-101 UPC Code 837654072196, Batch # 11652, 11727, 2441, 11870, 11884, 11955, 11969, 12005, 12006, 12029, 12057, 13008, 13193, 13199, 13221, 13242, 13271, 13288, 13325, 13514, 13521. |
Recalling Firm/ Manufacturer |
Quasar Bio-Tech, Inc. dba Silver Bay LLC 1431 Tallevast Rd Sarasota FL 34243-5035
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For Additional Information Contact | DeNette Adix 941-306-5812 |
Manufacturer 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 Determined Cause 2 | 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 DeNette@quasarbiotech.com 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = ILY
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