Recalls and Safety Alerts:
Hospira Inc., GemStar Infusion System: Recall
Damage from battery leakage may cause the device to shut off without warning…
Damage from battery leakage may cause the device to shut off without warning…
Newport Medical Instruments, Inc., HT70 and HT70 Plus Ventilators: Class I RecallThe
recall is in response to customer reports of ventilator alarming and
going into internal backup battery sooner than expected…
GE Healthcare, Giraffe OmniBed and Giraffe Incubator: Class I RecallAffected
devices may randomly delete stored information and enter new
information in its place (over-write) when the device turns “on” or
recovers from a power failure…
LifeScan, Inc. OneTouch Verio IQ Blood Glucose Meter – Class I RecallAt
extremely high blood glucose levels of 1024 mg/dL and above, the
OneTouch Verio IQ Meter will turn off instead of displaying the message
“EXTREME HIGH GLUCOSE above 600 mg/dL” as intended…
CareFusion Alaris PC Unit with Software V9.12: Class I RecallWhen
the unit experiences a communication error, the programmed infusion(s)
will continue as programmed but no further key presses will have an
effect on the system except for the System On key which allows the user
to power down the device…
Medical Bed Mattresses: FDA Safety CommunicationFDA
is concerned that fluid ingress from worn or damaged medical bed
mattress covers may be widespread and largely under-recognized by health
care providers, health care facility staff, and caregivers…
BCI Remote Alarm Cables By Smith's Medical ASD, Inc.: Class I RecallIn
rare instances, the BCI Remote Alarm Cables (BCI Cables) are not
transferring alarms when used with some remote nurse alarm systems…
Covidien
Endo GIA Articulating 60-3.5 Surgical Stapler Reloads with lot number
N3B0165LX were stolen from the manufacturer before they were sterilized.
Although these devices were packaged and labeled as sterile, they are
not sterile…
Discussions with Healthcare Providers:
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