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Safety

Recall -- Firm Press Release

 

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.

 

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

 

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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