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McKesson

MCKESSON MEDICAL-SURGICAL INC. · Model 1153 · UDI-DI 40612479199666

JAF Prescription
1
510(k) clearances
80
Adverse events (4 deaths)
8
Recalls
10
Facilities

Description

DOPPLER KIT, ABI W/PRINTER

Recalls

DateFirmReason
2023-02-10Unetixs Vascular, Inc.The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
2023-02-10Unetixs Vascular, Inc.The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
2023-02-10Unetixs Vascular, Inc.The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
2023-02-10Unetixs Vascular, Inc.The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
2017-06-09Natus Neurology IncSome of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood
2017-06-09Natus Neurology IncSome of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood
2017-06-09Natus Neurology IncSome of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood
2017-06-09Natus Neurology IncSome of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.