It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two lots.
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Infusion Pumps
🏥 Medical Devices • 4,350 recalls
Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.
Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.
Plum 360 Infusion System
ICU Medical
Class I - Dangerous
Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion.
Reagent 1 component may result in Quality Control values shifting out of acceptable range, which is not resolved by recalibration.
SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
Sorin Group USA
Class I - Dangerous
Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.
Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
Smiths Medical ASD
Class I - Dangerous
The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada.
CS 300 Intra-Aortic Balloon Pump
Maquet Datascope Corp - Cardiac Assist Division
Class I - Dangerous
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
CS 100i Intra-Aortic Balloon Pump
Maquet Datascope Corp - Cardiac Assist Division
Class I - Dangerous
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
CS 100 Intra-Aortic Balloon Pump
Maquet Datascope Corp - Cardiac Assist Division
Class I - Dangerous
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death.
When the user has not set up any user preference on the sorting order to render the study images (OS/OD/etc.) and reports, the ECP may get an incorrect study index. If the user attempts to delete an image, ECP may then read that image as OS when it is, in fact, OD.
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
Class I - Dangerous
Lot was not functioning properly and not exhibiting the correct physical properties.
Alaris Pump Module model 8100
CareFusion 303
Class I - Dangerous
There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100.
Olympic Pasteurmatic 3000/3500 Systems are recalled because they do not fully meet todays regulatory requirements. Given the age of the products design, component and technology obsolescence, and the time involved in fully complying with the latest design and development standards, the firm decided to recall of the Olympic Pasteurmatic 3000/3500 System devices by means of disabling the devices.
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.