Bright Embrace recall
Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
Why was Bright Embrace recalled?
Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial Numbers: 1002565 1002579 1002632 1002644 1002655 1002688 1002689 1002736 1002746 1002753-1002762 (10 units) 1002768-1002788 (21 units) 1002791-1002805 (15 units) 1002807-1002813 (7 units) 1002816-1002823 (8 units) 1002825-1002833 (9 units) 1002835-1002836 (2 units) 1002850-1002865 (16 units)
- Product
- Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
- Recalling firm
- Physician Engineered Products, Inc.
- Quantity
- 97 units
- Distribution
- Worldwide Distribution - US Distribution to the states of : CA, CO, FL, KY, MA, MD, NM, PA, TN, TX and VA., and to the countries of : Egypt, Honduras, Saudi Arabia and Singapore.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)