Device Recall Baxter

  • 모델명 / 제조번호(시리얼번호)
    catalog 2C6723, lot numbers UR144147 through UR158808. Please note: Baxter lot numbers are represented by an internal reference code ''UR'' followed by a six digit sequential number, or by the letter ''U'' followed by a six digit sequential number with and ''R'' suffix. Any lot number appearing within the identified six digit sequential number range is subject to the recall.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide, Mexico, Canada, Columbia, Australia, New Zealand and Taiwan
  • 제품 설명
    Baxter Y-Type Blood/Solution Set with Pressure Pump, 10 drops/mL, 99'', 170 to 260 Micron Filter,Large Standard Blood Filter, 2 Injection Sites, Male Luer Lock Adapter, catalog 2C6723; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Baxter Healthcare Corp., Rt 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
    Product code 5C4483, lot number H09E18044.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US (states of Arkansas, Illinois, Mississippi, North Carolina, Tennessee and Virginia) and El Salvador.
  • 제품 설명
    Baxter Minicap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp; six sets per carton; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 5C4483 The set is used in disconnect applications and cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler juncture.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Product code 2C8864; Lot number UR09E21238.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States (Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, Mississippi, Missouri, Nevada, New Mexico, Ohio, Tennessee, Texas, Utah and Wisconsin), Canada and New Zealand.
  • 제품 설명
    Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection Y-sites, 3 Luer Activated Valves and Male Luer Lock Adapter with Retractable Collar; 48 individually pouched sterile sets per case; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. || A sterile fluid pathway used to administer fluids from a container to a patient's vascular system through a vascular access device.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    All Baxter 1550 instruments and/or spare circuit boards that do not have software versions 3.0A or 4.1B
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States - nationwide and Puerto Rico, Argentina, Brazil, Canada, Chile, China, Colombia, Ecuador, Guatemala, Honduras, Mexico, Panama, Philippines, Romania, Turkey and Venezuela.
  • 제품 설명
    Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015; product codes 5M5538, 5M5538R, 5M5575, 5M5551 and 5M5551R.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot number: G076802
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    United States -- Nationwide and Puerto Rico, Canada and Saudi Arabia
  • 제품 설명
    Baxter RenAmin (Amino Acid) Injection; Pharmacy Bulk Package Not for Direct Infusion, Rx Only, 250 mL type II glass bottles; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, Made in USA; product code 2A6222.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: G075531, G076937, and G076794
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    United States -- Nationwide and Puerto Rico, Canada and Saudi Arabia
  • 제품 설명
    Baxter Evacuated Container, 250 mL, Sterile, non pyrogenic, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in USA, product code 1A8502.
  • Manufacturer
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