Voluntary Worldwide Field Corrective Action of the Vital Signs Hygroscopic Condenser Humidifier (HCH) / Anesthesia Breathing Cir

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Contact:
Consumer:
1-800-932-0760

Media:
Annette Busateri
GE Healthcare
annette.busateri@ge.com
+1 262 442 0966

FOR IMMEDIATE RELEASE - July 29, 2011 - In April 2011, Vital Signs Devices, a GE Healthcare Company, initiated a voluntary worldwide field correction of the Vital Signs Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit.  This device is sold under various part numbers - see list below.
   
The Vital Signs Devices Passive Humidification Device (Hygroscopic Condenser Humidifier or “HCH”) may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient (hypoxia or hypoxemia).  This device may be included in Vital Signs anesthesia circuits or sold separately.  The affected units were manufactured between January 2011 and April 2011.

GE Healthcare initiated the field correction in April 2011, and began notifying customers with affected units through an Urgent Medical Device Correction Letter and a follow-up call to confirm receipt of the letter.  Through these efforts, all customers were informed of the issue and provided with safety instructions.  Customers have been directed to NOT use the anesthesia circuits containing the Vital Signs Devices Passive Humidification Device (Hygroscopic Condenser Humidifier, or “HCH”), or the stand alone HCH device with the product item numbers and lot numbers listed below, isolate all affected product, contact Vital Signs Customer Service at 1-800-932-0760 to arrange for the return and replacement of product.  All affected Hygroscopic Condenser Humidifier and Anesthesia Breathing Circuits with affected Hygroscopic Condenser Humidifiers are being replaced.
 
The U.S. Food and Drug Administration (FDA) has classified this recall as a Class I recall. FDA defines Class I recalls as “a situation in which there is a reasonable probability that the use of or exposure to the volatile product will cause serious adverse health consequences or death.”
 
For additional information regarding this field correction, please contact Vital Signs Customer Service at 1-800-932-0760.Hours of Operation: 8:00 am EST to 5:00 pm EST, Monday through Friday.
 

Product	Lot #		Product	Lot #		Product	Lot #		Product	Lot #
5020AEHM	11087A		A5632X15	11070A		A5U5201XX1	11076B		ADU12914	11074A
	11098B			11095A			11083A			11074B
5701	5301C		A565192X	11094A			11088A			11075A
	5344E			11095A			11090A			11087A
	5348V			11095B			11101A			11090B
	5353K			11096A		A5W32014	11077A			11094B
	5366T			11097A			11090B			11098B
5701E	5346Z		A5U32020	11070A		A5Z51914	11069B			11101A
5702	5301D			11070B			11070A			11101B
A0F52014	11091A			11074B			11084A		ADU52914	11073A
	11098B			11077B			11097B			11074A
A4112X14	11070A			11081A		A8T52914	11082B			11075A
A415112A	11098B			11081B		A8U52015	11069A			11077A
A41X2X24	11092A			11083A			11075A		ADW32014	11073A
A4612X2C	11077A			11087A			11075B			11083A
	11081B			11087B			11083B			11087A
	11095B			11090A			11091A			11094A
	11098A			11092A			11101B			11098A
A4F12014	11075A			11094B		A8U5211X	11094A			11098B
	11084B			11097A		A8U52X14	11075A			11101A
	11090B			11098A			11077A		AFN52024	11074A
	11091A			11101A			11083A			11083B
	11094A			11102A			11090B			11084A
	11101B			11102B		A8W52914	11069A			11091B
	11091A		A5U32414	11077B			11083A			11096A
	11101A			11080A			11088A			11098B
A4F52X10	11075B			11082A			11094A		AFN5291C	11069B
	11077B			11082B		A9U5211X	11080A			11070B
	11082A			11090A			11090B			11083A
	11090A			11094A			11094A			11090A
A4F52X14	11074B			11094B		AD132X14	11073A			11098A
A4U12214	11080B			11097A			11074A		AFN52X1X	11070B
	11092A			11097B			11075A			11088A
	11097A			11098A			11088A		AFR5191X	11069B
	11098A		A5U32X14	11076B			11095B		AFR58014	11069B
	11101A			11083B			11096B			11076A
A4U52X1X	11083A			11084A		AD152914	11074B			11098B
	11087A		A5U32X24	11070A		AD632X11	11070A			11101A
	11090A			11077A			11073A			11101B
A5152914	11077B			11080A			11074A		AFR5XX20	11073B
	11080A			11083B			11081A			11101A
A52X2314	11081A			11087B			11083A		AGN1QX1C	11070A
	11091A			11098B		ADA52014	11076A			11070B
	11096B			11101A		ADG5291X	11101B