Devices

Device Recall Vacutainer

  • 모델명 / 제조번호(시리얼번호)
    Catalog No. 367841 Lot No. 6279849 UDI: (01)30382903678410
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. || Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
  • Manufacturer
    Becton Dickinson & Company
  • 1 Event

제조사

Becton Dickinson & Company
  • 제조사 주소
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA

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Device Recall Vacutainer Tubes
  • 모델명 / 제조번호(시리얼번호)
    Part Number/Product Number  ILEY029-01 ULKY005-14 LOUS015-03 DNAZ017-01  ILEY029-02 SERA003-07 TENN016-05 DONS008-05 EVER007 SERA005-07 LANC029-06 STLM007-10 CCHM024-03  Part Number/Product Number  LANC015-27 CCHM027-04 STLM003-11 ABIN137-01 ABIN110-01 LANC015-28 MONT045-03 ILEY003-53 NAFB015-07 ILEY014-21 ILEY034-04 ILEY034-05  Part Number/Product Number  AV10654-10 ILEY014-22 EVER010 EVER001 SOHS016-03 SSHH118-03 SSHH117-06 SOHS017-03 HCMH009-05 WIME023-08 TUFT040-05  Part Number/Product Number  TUFT039-08 HCMH009-06 GIFT022-01 TUFT040-06 PCHM004-07 HLDH008-04 WHWC005-17 PCHM008-04 LANC015-25 PCHM011-03
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    All products are distributed through distribution centers confined to the US. All end-users for these products are also solely located in the US.
  • 제품 설명
    Vacutainer Tubes || Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing, and CBC testing.
  • Manufacturer
    Avid Medical, Inc.
Device Recall Vacutainer
  • 모델명 / 제조번호(시리얼번호)
    Catalog # -- Lot #:  367352 -- 5188576; 367352 -- 5208448; 367352 -- 5217290; 368656 -- 5164491; 368656 -- 5164526; 368656 -- 5187894; 368656 -- 5192496; 368656 -- 5220204; 368656 -- 5238936.
  • 의료기기 분류등급
    Hematology and Pathology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The device was shipped to 23 wholesalers, 5 hospitals, and 1 VA govt. account nationwide.
  • 제품 설명
    BD Vacutainer Push Button Blood Collection Set with Pre-Attached holder.
  • Manufacturer
    Becton Dickinson & Company