|[December 30, 2013]
Voluntary Field Corrective Action Initiated for Vital Signs Device's CO2 Multi Absorber Due to a Health Risk
TOTOWA, N.J. --(Business Wire)--
Vital Signs Devices, a GE Healthcare Company, has initiated a voluntary
field corrective action of the disposable Multi Absorber Original after
becoming aware of a potential safety issue due to air leakage associated
with the CO2 Multi Absorber. The Multi Absorber Original may have a thin
wall condition which may lead to small holes in the water (drain tube).
This may result in a loss of anesthetic gases, ventilation and
The voluntary corrective action was issued after receiving customer
complaints and product returns; upon further inspection the returned
absorbers were found to leak due to a hole in the drain tube. The
affected product number is M1173310 containing lot numbers 12001 through
13031. Not affected are products with lot numbers 13032 and higher.
Vital Signs has notified all customers with affected units through an
Urgent Medical Device Correction letter, which alerts uses of the
concern and safety instructions. Vital Signs is also following up with
all customers and will replace all affected units at no cost to
customers. You can access the original customer letter by visiting here.
To date, no patient injuries have been reported with regards to this
For additional information regarding this corrective action, please
contact Customer Service (domestic) at 800-345-2700 (option 2 followed
by option 2) if you have any questions or concerns. You may also contact
International Customer Service at +1-800-932-0760 (option 2). Hours of
Operation: Monday to Friday from 8:00 am EST to 5:00 pm EST.
Adverse reactions or quality problems experienced with the use of this
product may be reported to the FDA:
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