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Philips HeartStart XL+ Defibrillator/Monitor Model: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defibrillation. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes the use of an AED. When operating in Monitor, Manual Defibrillation or Pacing modes, the HeartStart XL+ is suitable for use by healthcare professionals trained in advance life support. Class II

Reason: HeartStart XL+ battery charge time to 100% capacity at 35¿C (95¿F) is slightly longer than the specified 3 hour duration as stated in the labeling

Philips Medical Systems, Inc. 20140124 Terminated
Distributed: Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of ALGERIA ANGOLA ARGENTINA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BELGIUM BOLIVIA BULGARIA CANADA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK DOMINICAN REPUBLIC EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND FRANCE GABON GERMANY GREECE GUATEMALA HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAN (ISLAMIC REPUBLIC OF) IRAQ IRELAND ISRAEL ITALY JORDAN KENYA KOREA, REPUBLIC OF KUWAIT LATVIA LEBANON LIBERIA LIBYAN ARAB JAMAHIRIYA LITHUANIA MACAU MALAYSIA MALTA MAURITIUS MOROCCO MYANMAR (Burma) NAMIBIA NETHERLANDS NEW ZEALAND NORWAY OMAN PALESTINE PERU PHILIPPINES POLAND PORTUGAL,QATAR ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SENEGAL SERBIA SEYCHELLES SINGAPORE SLOVAKIA (Slovak Republic) SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND SYRIAN ARAB REPUBLIC TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and VIET NAM.
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Optiflux F18Nre Flux Dialyzers; Product Number: 0500308E. Single Use acute or chronic hemanalysis treatment. Class II

Reason: Dialysate Port Leak During Priming of the Dialyzers

Fresenius Medical Care Holdings, Inc. 20140204 Terminated
Distributed: Worldwide distribution: USA (nationwide) and the country of: Mexico.
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Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment. Class II

Reason: Dialysate Port Leak During Priming of the Dialyzers

Fresenius Medical Care Holdings, Inc. 20140204 Terminated
Distributed: Worldwide distribution: USA (nationwide) and the country of: Mexico.
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Optiflux F200A High Flux Dialyzers; Product Number: 0500320A. Single Use acute or chronic hemanalysis treatment. Class II

Reason: Dialysate Port Leak During Priming of the Dialyzers

Fresenius Medical Care Holdings, Inc. 20140204 Terminated
Distributed: Worldwide distribution: USA (nationwide) and the country of: Mexico.
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Optiflux F200NR High Flux Dialyzers; Product Number: 0500320N. Single Use acute or chronic hemanalysis treatment. Class II

Reason: Dialysate Port Leak During Priming of the Dialyzers

Fresenius Medical Care Holdings, Inc. 20140204 Terminated
Distributed: Worldwide distribution: USA (nationwide) and the country of: Mexico.
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Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment. Class II

Reason: Dialysate Port Leak During Priming of the Dialyzers

Fresenius Medical Care Holdings, Inc. 20140204 Terminated
Distributed: Worldwide distribution: USA (nationwide) and the country of: Mexico.
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Optiflux F180NR High Flux Dialyzers; Product Number: 0500318N. Single Use acute or chronic hemanalysis treatment. Class II

Reason: Dialysate Port Leak During Priming of the Dialyzers

Fresenius Medical Care Holdings, Inc. 20140204 Terminated
Distributed: Worldwide distribution: USA (nationwide) and the country of: Mexico.
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Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E. Single Use acute or chronic hemanalysis treatment. Class II

Reason: Dialysate Port Leak During Priming of the Dialyzers

Fresenius Medical Care Holdings, Inc. 20140204 Terminated
Distributed: Worldwide distribution: USA (nationwide) and the country of: Mexico.
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Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N. Single Use acute or chronic hemanalysis treatment. Class II

Reason: Dialysate Port Leak During Priming of the Dialyzers

Fresenius Medical Care Holdings, Inc. 20140204 Terminated
Distributed: Worldwide distribution: USA (nationwide) and the country of: Mexico.
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Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E. Single Use acute or chronic hemanalysis treatment. Class II

Reason: Dialysate Port Leak During Priming of the Dialyzers

Fresenius Medical Care Holdings, Inc. 20140204 Terminated
Distributed: Worldwide distribution: USA (nationwide) and the country of: Mexico.
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