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

Posted Aug 01 2011 11:21am
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

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

    
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