Reported Sep 9, 2015 · Terminated
Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model…
Physician Engineered Products, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Physician Engineered Products, Inc. · 103 Smith St · Fryeburg, ME · 04037-1182
Is this the product you have?
- Bright Embrace, a Single Bili Light
- for newborn phototherapy Distributed byPhysician Engineered Products, Inc., Model SBL60
- Lot codes and dates
- Serial Numbers(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)
1002565100257910026321002644100265510026881002689100273610027461002753-1002762
- Serial Numbers
- Amount recalled
- 97 units
Where it was sold
Why it was recalled
Upper limit for ambient temperature for use of the device was printed incorrectly in the instructions
This product could cause temporary or reversible health problems — stop using it.
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