Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.
Terumo Cardiovascular Systems
Class I - Dangerous
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S
Compass Health Brands (Corporate Office)
Class I - Dangerous
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000
Stryker Medical Division of Stryker
Class I - Dangerous
The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.
Class I - Dangerous
Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S
Compass Health Brands (Corporate Office)
Class I - Dangerous
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Class I - Dangerous
Devices were delivered without the required dry ice.
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Shippert Medical Technologies
Class I - Dangerous
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).
Philips North America
Class I - Dangerous
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Shippert Medical Technologies
Class I - Dangerous
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
Class I - Dangerous
Devices were delivered without the required dry ice.
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.