Devices

Epidural Needle

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  Product code AN-05501:  13F17A0211 13F17B0082 13F17C0378 13F17D0082 13F17E0023 13F17E0329 13F17E0838 13F17F0432 13F17F0813 13F17G0333 13F17H0059 13F17J0002 13F17L0598 Product code AN-05505:  13F17A0213 13F17C0109 13F17C0479 13F17E0208 13F17F0254 13F17F0727 13F17G0357 13F17J0161 13F17J0274 13F17L0441
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM
  • 제품 설명
    Epidural Needle; Product Codes: AN-05501 and AN-05505
  • Manufacturer
    Arrow International Inc
  • 1 Event

제조사

Arrow International Inc
  • 제조사 주소
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA

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Device Recall ARROW Epidural Needle Component
  • 모델명 / 제조번호(시리얼번호)
    Product number AN-05501, Lot numbers: 23F13J0530, RF2108954, RF6127264, RF8045530, RF0021370, RF3014600, RF6127624, RF8070744, RF0035171, RF3026989, RF7031498, RF8083748, RF0050648, RF5084669, RF7043570, RF8096949, RF0075647, RF5094931, RF7088907, RF8123534, RF0092301, RF5106225, RF7090151, RF9015869, RF2021938, RF5118327, RF7102346, RF9030002, RF2044557, RF5120725, RF7113197, RF9071402, RF2058276, RF6081852, RF8018337, RF9098526, RF2083791, RF6092570, RF8020947, and RF9113319.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution US Nationwide, Canada and Mexico.
  • 제품 설명
    ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement.
  • Manufacturer
    Arrow International Inc
Device Recall RX2 COUDE Epidural Needle
  • 모델명 / 제조번호(시리얼번호)
    Lot No. 12168200; Ref No. 107-1416.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
  • 제품 설명
    RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, For Use with 19g or Smaller Catheter
  • Manufacturer
    Epimed International
Device Recall TUOHY Epidural Needle
  • 모델명 / 제조번호(시리얼번호)
    Lot No. 12358202; Ref No. 125-2035T.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
  • 제품 설명
    TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
  • Manufacturer
    Epimed International
Device Recall Epidural Needle
  • 모델명 / 제조번호(시리얼번호)
    Lot No. RF4044686, expiration date 2006-09
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The recalled kits with the wrong epidural needle was distributed to the following direct accounts, to the following states in TN and TX
  • 제품 설명
    ARROW EPIDURAL CATHETERIZATION KIT. Product No. MC-05001.
  • Manufacturer
    Arrow International Inc
Portex Spinal Epidural Needle Sets
하나 더 4 건 더