Quasar MD is an infrared LED lamp that is labeled in part: "***QUASAR MD***Bringing the Spa Home***Radiant and Youthful
FDA device recall Z-0518-2013 · posted 2012-12-12 · Terminated
Recall details
- Recalling firm
- Quasar Bio-Tech, Inc. dba Silver Bay LLC
- 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.
- Action taken
- 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.
- Root cause
- No Marketing Application
- Status
- Terminated
- Product code
- ILY
- Quantity affected
- 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, Cayma
- Date initiated
- 2012-10-25
- Date posted
- 2012-12-12
- Date terminated
- 2013-05-21
- Location
- Sarasota, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PAINACEA MODEL XR8 INFRARED HEAT LAMP (K051046) | Atlantis Luminescent Products, LLC | 2005-05-10 |