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Vital Signs

Carefusion Finland 320 Oy · Model 9446-910 · UDI-DI 10885403258374

DQE Prescription

510(k) clearances

1,067

Adverse events (24 deaths)

Recalls

Facilities

Description

Cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft

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.