Medstorm Adult Radiolucent Electrode Philips Medical , Part #16250

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1) Medstorm Adult Radiolucent Electrode Philips Medical , Part #16250.
The Adult Radiolucent Multifunction Tin Electrodes are indicated for
use
in external pacing, defibrillation and monitoring applications as a
non-sterile, disposable device for single patient use only. The
electrodes provide the conductive interface between the defibrillator
and/or the external transcutaneous cardiac pacemaker and the patients
skin. When a patient requires defibrillation, cardioversion or
external
pacing, these electrodes will be applied to the patient and connected
to
the respective low power mono-phasic or bi-phasic defibrillator (360
joules maximum) or external pacemaker. Recall # Z-1371-2011;
2) Medstorm Adult Radiolucent Zoll Medical (Part # 16381. The Adult
Radiolucent Multifunction Tin Electrodes are indicated for use in
external pacing, defibrillation and monitoring applications as a
non-sterile, disposable device for single patient use only. The
electrodes provide the conductive interface between the defibrillator
and/or the external transcutaneous cardiac pacemaker and the
patient’s
skin. When a patient requires defibrillation, cardio version or
external
pacing, these electrodes will be applied to the patient and connected
to
the respective low power mono-phasic or bi-phasic defibrillator (360
joules maximum) or external pacemaker. Recall # Z-1372-2011
CODE
1) Lot Y-032709;
2) Lot # Y032709-1
RECALLING FIRM/MANUFACTURER
Heart Sync, Inc., Ann Arbor, MI.
Manufacturer: Katecho Inc., Des Moines, IA. FDA initiated recall is
ongoing
REASON
The seal on the electrode pouch may be open, exposing the electrode to
the outside environment. The package does have a caution statement
that
states, " Do not open package until immediately prior to using
electrodes. and Electrodes may dry out when removed from packaging and
exposed to air.
VOLUME OF PRODUCT IN COMMERCE
600 products (300 each)
DISTRIBUTION
Nationwide and Canada
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