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Masimo SpO2b Module w/ cable & sensor

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Model 115-047244-00 · UDI-DI 06936415905590

DQE Prescription

510(k) clearances

1,088

Adverse events (24 deaths)

Recalls

Facilities

Recalls

Date	Firm	Reason
2021-07-09	Edwards Lifesciences, LLC	There is a potential for internal leaks within catheters.
2021-07-09	Edwards Lifesciences, LLC	There is a potential for internal leaks within catheters.
2021-07-09	Edwards Lifesciences, LLC	There is a potential for internal leaks within catheters.
2021-07-09	Edwards Lifesciences, LLC	There is a potential for internal leaks within catheters.
2021-07-09	Edwards Lifesciences, LLC	There is a potential for internal leaks within catheters.
2021-07-09	Edwards Lifesciences, LLC	There is a potential for internal leaks within catheters.
2020-03-27	Edwards Lifesciences, LLC	Sterile catheter kit packaging compromised.
2020-01-02	ICU Medical, Inc.	Inability for the guidewire to pass through the needles included with the catheter kits.
2020-01-02	ICU Medical, Inc.	Inability for the guidewire to pass through the needles included with the catheter kits.
2020-01-02	ICU Medical, Inc.	Inability for the guidewire to pass through the needles included with the catheter kits.

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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.