Device Recall Abbott

  • Modelo / Serial
    All lots of 9402212 and ALL lower numbers.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Product was released for distribution to 428 consignees in U.S. and 17 foreign consignees. The U.S. States include: AL, AZ, CA, CO, FL, GA, IA, MN, MO, NY, NC, SC, TN, TX and UT; and foreign accounts include: Argentina, Canada and Puerto Rico. Product was distributed to 10 U.S. Government accounts: (1) AK Native Med Center Supply 4315 Diplomacy Dr. Anchorage, AK 99508 907-729-1200 (2) Walter Reed Army Medical 6900 georgia Ave. NW Washington DC 20307 202-782-2579 (3) WHMC Medical material Mgr. 2200 Bergquest Dr. lackland AFB, TX 78236 (210)-670-7505 (4) DD Eisenhower AMC PAT E. Hospital Rd. Fort Gorden, GA 80220 (706) 791-2430 (5) VA Medical Center 1055 Claremont St. Denver, CO 80220 (303) 399-8020 (6) VA Hospital Supply 500 Foothill Dr. Salt Lake City, UT 84148 (801) 584-1248 (7) WHMC Medical Material Mgr. 2200 Bergquist Dr. Lackland AFB, TX 78236 (210) 670-7505 (8) VA Medical Center 650 E. Indian School Rd. Phoenix, AZ 85012 (602) 277-5551 (9) VA Medical Center 109 Bee St. Charleston, SC 29401 (843) 577-5011 (10) USPHS Phoenix 4212 N. 16th St. Phoenix, AZ 85016 (602) 263-1585
  • Descripción del producto
    Abbott brand DILUENT/SHEATH, CELL-DYN¿ 4000 System || CELL-DYN REAGENT PART A || Model/List Number 01H77-01 (4x3.8L), 01H75-01A (3.8L)
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Abbott Laboratories, 5440 Patrick Henry Drive, Santa Clara CA 95054
  • Source
    USFDA

50 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    All lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusive.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Internationally to China, Lebanon, Costa Rica, Singapore, Brazil, Jordan, Russia, Greece, Austria, India, Nigeria, United Kingdom, Korea, Saudi Arabia, Morocco, Slovenia, Portugal, Tunisia, Kazakhstn, Qatar, U.A.E. Israel, Taiwan, Mexico, Argentina, Poland, Italy, Hong Kong, Kuwait, Switzerland, Turkey, Ireland, Chile, Germany, and Australia.
  • Descripción del producto
    i-Stat PT/INR Cartridges || List number 03P89-24 || The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. || a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.
  • Manufacturer
  • Modelo / Serial
    Product List Number 07K7220 with Lot #: 55900UI01with expiration date of 04/23/2016, Lot #: 55908UI01 with expiration date of 04/29/2016, Lot #: 55941UI00 with expiration date of 04/23/2016, Lot #: 57929UI00 with expiration date of 07/16/2016, Lot #: 57931UI01 with expiration date of 07/27/2016, Lot #: 60105UI00 with expiration date of 10/02/2016 and Lot #: 61106UI00 with expiration date of 11/27/2016.  Product List Number 07K7225 - Lot #: 55900UI00 with expiration date of 04/23/2016, Lot #: 55908UI00 with expiration date of 04/29/2016, Lot #: 57929UI01 with expiration date of 07/16/2016, Lot #: 57931UI00 with expiration date of 08/27/2016, Lot #: 60105UI01 with expiration date of 02/10/2016, Lot #: 61106UI01 with expiration date of 11/27/2016 and Lot #: 62263UI00 with expiration date of 11/27/2016.
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- US, to the following states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY; and, the countries of ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVI, BRAZIL, BRUNEI, BULGARIA, CAMEROON, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GAZA & JERICHO, GEORGIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, IVORY COAST, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALDIVES, MALI, MAURITIUS, MEXICO, MONTENEGRO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REPUBLIC OF YEMEN, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TOGO, TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM and ZIMBABWE.
  • Descripción del producto
    The ARCHITECT Estradiol Kit || Intended to measure estradiol, an estrogenic steroid, in plasma.
  • Manufacturer
  • Modelo / Serial
    list 3B42-50, lot 86504M300
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Ecuador, England, Hong Kong, Chile, Japan, Canada, Singapore, Australia, Pakistan, Argentina, Thailand, Aruba, Korea and Jamaica.
  • Descripción del producto
    Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with Master Calibrator 1 having 0 U/mL and Master Calibrator 2 having 60 U/mL; Abbott Laboratories, Abbott Park, IL 60064
  • Manufacturer
  • Modelo / Serial
    List number 15252-04-02, lot 940285H
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    New Orleans, LA
  • Descripción del producto
    T-U-R Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Irrigation Container System, 84 inch (213 cm) Nominal Length, No. 15252-02; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064
  • Manufacturer
  • Modelo / Serial
    List number 19020-04-12, lot 941845H
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Miami, FL
  • Descripción del producto
    Abbott Latex-Free Primary I.V. Plumset Convertible Pin, 95 inch with Injection Site and Secure Lock, No. 19020; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064
  • Manufacturer
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