Reported Jun 13, 2018 · Terminated
Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a…
Draeger Medical Systems, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Draeger Medical Systems, Inc. · 3135 Quarry Rd · Telford, PA · 18969-1042
Is this the product you have?
- Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of hyperbilirubinemia. It is to be used in conjunction with other clinical signs and laboratory measurements. The Jaundice Meter is not intended for home use. The Jaundice Meter may only be used at the sternum measurement site for Physician s office applications
- Lot codes and dates
- All products
- Amount recalled
- 10363
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
Users have misinterpreted the display for out of range measurement indicated by the blinking" ---" to mean a zero measurement.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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