Date Initiated by Firm |
April 29, 2011 |
Date Posted |
July 30, 2011 |
Recall Status1 |
Terminated 3 on August 06, 2014 |
Recall Number |
Z-2848-2011 |
Recall Event ID |
59047 |
Product Classification |
Anesthesia Breathing Circuit - Product Code BYD
|
Product |
Vital Signs- A GE Healthcare Company - Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit; GE Medical Systems SCS 283 rue de la Miniere 78530 BUC, France p +33.1.30.70.40.40; Vital Signs Colorado Inc 11039 E. Lansing Circle Englewood, CO 80112 P +1.973.956.5300.
The intended use of the device is to provide proper flow of the medical gases or oxygen to patients under anesthesia or ventilation. |
Code Information |
Medical Device Listing number D110120. 5020AEHM 11087A 11098B 5701 5301C 5344E 5348V 5353K 5366T 5701E 5346Z 5702 5301D A0F52014 11091A 11098B A4112X14 11070A A415112A 11098B A41X2X24 11092A A4612X2C 11077A 11081B 11095B 11098A A4F12014 11075A 11084B 11090B 11091A 11094A 11101B 11091A 11101A A4F52X10 11075B 11077B 11082A 11090A A4F52X14 11074B A4U12214 11080B 11092A 11097A 11098A 11101A A4U52X1X 11083A 11087A 11090A A5152914 11077B 11080A A52X2314 11081A 11091A 11096B A5632X15 11070A 11095A A565192X 11094A 11095A 11095B 11096A 11097A A5U32020 11070A 11070B 11074B 11077B 11081A 11081B 11083A 11087A 11087B 11090A 11092A 11094B 11097A 11098A 11101A 11102A 11102B A5U32414 11077B 11080A 11082A 11082B 11090A 11094A 11094B 11097A 11097B 11098A A5U32X14 11076B 11083B 11084A A5U32X24 11070A 11077A 11080A 11083B 11087B 11098B 11101A 11102B A5U5201XX1 11076B 11083A 11088A 11090A 11101A A5W32014 11077A 11090B A5Z51914 11069B 11070A 11084A 11097B A8T52914 11082B A8U52015 11069A 11075A 11075B 11083B 11091A 11101B A8U5211X 11094A A8U52X14 11075A 11077A 11083A 11090B A8W52914 11069A 11083A 11088A 11094A A9U5211X 11080A 11090B 11094A AD132X14 11073A 11074A 11075A 11088A 11095B 11096B AD152914 11074B AD632X11 11070A 11073A 11074A 11081A 11083A ADA52014 11076A ADG5291X 11101B ADU12914 11074A 11074B 11075A 11087A 11090B 11094B 11098B 11101A 11101B ADU52914 11073A 11074A 11075A 11077A ADW32014 11073A 11083A 11087A 11094A 11098A 11098B 11101A AFN52024 11074A 11083B 11084A 11091B 11096A 11098B AFN5291C 11069B 11070B 11083A 11090A 11098A AFN52X1X 11070B 11088A AFR5191X 11069B AFR58014 11069B 11076A 11098B 11101A 11101B AFR5XX20 11073B 11101A AGN1QX1C 11070A 11070B AGN5241C 11071A 11073A 11074B 11091A 11091B 11094A AIN52014 11070A 11074A 11075A 11076A 11082B 11083B 11087A 11087B 11090A 11095B 11101A AXXXX111 11075A 11098A AXXXXX83 11095B AXXXXX89 11095B B1154X14 11076A 11095A B1353X2X 11095A B1514X11 11073A 11098B B1534X15 11074B 11077B 11090A 11096A B1734X1Z 11069A 11091A B8734X24 11070A 11074A 11088A B9154X14 11073B 11098B G64X0XAX 11076B 11098A GABCXXXX 11087B 11088B 11094A 11096A GAK1OXXX 11076A 11076B 11083B 11084A 11084B 11087A 11087B 11088A 11095A 11095B 11096B 11097A GCEXXXXA 11082B 11087B 11097A 11098A GCRCKXXX 11070A 11091A GE9C0XAX 11083B 11101B GF1XXXAX 11070A 11084A 11088A 11088A 11101B GF7FOXGX 11069B 11083A 11083B GFJCXXXX 11084A 11102A GGYF0XAX 11080A 11098B GHAFXXXX 11080B 11082B 11087A 11088B 11094A 11094B 11094B 11095B 11098B GHBXXXXA 11070A 11070B 11075A 11087B 11091A 11095A GKXFXXAX 11073B 11080A 11094B GMAXXXJX 11094A 11098A 11098B GT1XXXJX 11070A GWKXXXGX 11074A 11083A 11090A 11098B GXXXXX67 11069B 11070A 11081A 11081B 11084B 11084B GXXXXX97 11073A 11101A GXXXXXX3 11087A 11094B |
Recalling Firm/ Manufacturer |
Vital Signs Devices, a GE Healthcare Company 20 Campus Rd Totowa NJ 07512-1210
|
For Additional Information Contact |
Ms. Gwen Braeger 262-548-2608
|
Manufacturer Reason for Recall |
The Hygroscopic Condenser Humidifier (HCH) device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient.
|
FDA Determined Cause 2 |
Device Design |
Action |
An "Urgent Medical Device Correction" letter with the return confirmation form was sent to affected customers. Phone calls were also placed to customers. Consignees were informed of the affected device, issue, and actions to take. Customers were instructed to isolate all affected product, arrange return by contacting Customer Service at 1-800-932-0760, and return only unused product. Customers were asked to complete the attached confirmation form and fax back as per the instructions. For questions, contact your local Vital Signs Account Manager or call Customer service at 1-800-932-0760. |
Quantity in Commerce |
222,009 |
Distribution |
Worldwide Distribution including the United States. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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