Voluntary
Recall
Laerdal Medical is announcing a voluntary recall of certain Cat.No.85
12 02 Pressure Regulator Assembly components, specifically, those bearing
the number "4" molded into the plastic Regulator Cap. Approximately
700 Pressure Regulators marked "4" distributed in North America
between July 9, 2001 and March 9, 2002 are being recalled. This voluntary
recall was initiated by the manufacturer Laerdal Medical AS, Norway,
and is being facilitated by its distributor, Laerdal Medical Corporation,
New York.
Pressure
Regulator Assembly
The affected
part marked "4" was included in products distributed in the
period between July 9, 2001 and March 9, 2002. Note: Regulators marked
with the numbers "2", "3", or "5" were
produced and delivered during the same time period. However, they are
unaffected and are not being recalled. Parts marked number "4"
will be found in approximately 25% of the 15 items listed below that
were produced and shipped during that period.
Reason
for Recall
An irregularity was discovered in the molding of some Pressure Regulator
Caps marked number "4". This anomaly could prevent or impede
free movement of the spring-loaded Valve Stem in some Pressure Regulators,
perhaps leading to a malfunction of the Laerdal Silicone Resuscitator.
Potential
Consequences
Malfunction of the Pressure Regulator could mean that in some cases
a pressure greater than the specified 45 cmH20 would be necessary to
open the Pressure Regulator. Potential consequence for patients - Delivery
of higher than intended airway pressures. Additionally, once opened,
the Pressure Regulator may become stuck and remain in the open position.
Potential consequence for patients - Inability to ventilate efficiently
due to leakage of breathing gas from open regulator to atmosphere. Accordingly,
all regulators marked with the number "4" delivered during
July, 2001 to March, 2002 period are being recalled.
To date, no patient-related
malfunction, complaint, or incident has been reported, and the molding
irregularity has been resolved.
Contact Tracy Lochard,
Event Facilitator, NNC Group at 1-800-668-4391 for instructions and
to receive replacement parts at no charge.
