Vital Signs Devices, a GE Healthcare Company

Expiration for kit is four years.   Oz Masks  #D075986 Class I Exempt Device  If you have purchased directly from Vital Signs, the product codes affected are: 7700BAW2, 7700GAW2, 7700OAW2, 7700PAW2, 7700RAW2, 7700WAW2, 7700YAW2, Kits with masks included: 7730ALS, 7730BLU5, 7730FLY, 7730GRN5, 7730IALS, 7730MOD, 7730ORG5, 7730PUR5, 7730RED5, 7730WHI5, 7730YEL5. If you have purchased directly from Armstrong Medical, the Product Codes affected are: AE-4700 AE-4712, AE-4701, 7730RED, 7730PUR, 7730YEL, 7730WHI, 7730BLU, 7730ORG, 7730GRN, 7700RAW, 7700PAW, 7700YAW, 7700WAW, 7700BAW, 7700OAW, 7700GAW " Lot numbers of the affected modules are: 2009 K109 through K365 2010 P001 through P149510 (k) : K781055; Medical Device Listing   Blood Pressure Cuffs  If you have purchased directly from Vital Signs, the product codes affected are: BP4030BR, BP4530BR, 7730POCH, 7730IALS If you have purchased directly from Armstrong Medical, the product codes affected are: AE-4703, AE- 4700, AE-4706, AE-4707 " Lot numbers affected are: For the year 2009 LOT Number 2689 through LOT Number 3659 For the year 2010 LOT Number 0010 through LOT Number 2530 Any lot number that ends in the number 1 is NOT affected by the recall.

Anesthesiology Devices

1

No

IL

Broselow/Hinkle Pediatric Emergency System, Vital Signs Inc., 20 Campus Road, Totowa, NJ 07512 USA || The kit contains oxygen masks and blood pressure cuffs use on pediatric patients

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

Anesthesiology Devices

1

No

Worldwide Distribution including the United States.

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.

K060537 D071942 Serial numbers: 00110412 00110497 00111507 00111633 00111718 00111719 00111816 00111835 00110790 00110946 00111686 00111691 00111916 00111764 00111787 00111897 00111939 00112078 00112200 00111880 00111906 00111733 00111664 00111668 00111672 00111673 00111699 00111745 00111749 00111771 00111773 00111786 00111807 00111817 00111832 00111865 00111886 00111891 00111898 00111954 00111975 00111996 00111997 00112042 00112071 00112106 00111703

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA (nationwide) and the country of Vietnam

enFlow IV Fluid Warmer Part number 980105VS; || (510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, Model 200 and EFlow AC Power Supply Model 120) || Intended for warming blood, blood products, and intravenous solutions, prior to administration. Intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

a) 510(k): K060537 b) Medical device listing number: D071942  All enFlow Warmer Straps in the field present a potential for tissue injury. Sold separately as Product #: 980304 and 980304EU Included as an accessory in following enFlow products:  Military Domestic 91000153 980100 91000154 980100EU 91000156 980105VS 91000103

General Hospital and Personal Use Devices

2

No

Nationwide Distribution.

enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL || 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, || MODEL 120). || The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia.

GE product number M1024229

General Hospital and Personal Use Devices

2

No

Worldwide distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Poland, Saudi Arabi, Singapore, South Africa, Spain, Sweden and United Kingdom.

Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. || Continuous temperature monitoring.