Device Recall Pall

  • 모델명 / 제조번호(시리얼번호)
    Part Number RP640F0D0, 20 per case, Lot Numbers: 575951104, 596600105; Part Number RP660F0D0, 20 per case, Lot Number: 596610105
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Product was distributed domestically to customers in CA, AZ, IL, CO, OR, FL, VA, OH, MI, and UT. Product was also distributed to the following foreign countries: Malaysia, Mexico, and New Zealand
  • 제품 설명
    Circuit- Matching Kit, 40'' Adult, 3L LPF, single use, Part Numbers RP640F0D0 and RP660F0D0. Manufactured for Pall Life Sciences, Ann Arbor, Michigan. Made in Mexico.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    MMS Sales Corp, 218 Highline Rd, Pharr TX 78577-9726
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 4 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Catalog No. MR58-050; Known Lot No. WNV101020.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution - US including CA and VA.
  • 제품 설명
    PALLAS M/MAXIMIS 50mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Exp. date 2015-07: Lots 032711, 032811, 033611 and 033711 Exp. date 2016-01: Lots 105912 and 106012
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) including the states of CA, CO, CT, IL, KS, LA, MA, MO, MS, NC, NY, OK, SD, TX, WA, and WY, and Puerto Rico and the countries of Colombia and Costa Rica.
  • 제품 설명
    Pall Total Nutrient Admixture Filter, 1.2 micron filter || This filter is a 1.2 micron low protein binding membrane indicated for the removal of inadvertent particulate debris and microorganisms (Candida Albicans) from total nutrient admixtures and undiluted intravenous fat emulsions. Product is designed for use with intravenous infusion pumps only.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Catalog/Model/Reorder Number: LGB Lot # 10-405
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide (USA) Distribution including the states of CA, LA, MI, TX and WI.
  • 제품 설명
    PALL Medical LeukoGuard¿ LGB Arterial Line Leukocyte Reduction Filter with Bypass Loop, STERILE. CATALOG/MODEL/Reorder Number: LGB. CLASSIFICATION NAME: Filter, Blood, Cardiopulmonary Bypass Arterial Line. COMMON/USUAL NAME: Arterial Line Filter with Bypass Loop. -- Manufactured by: PALL NEWQUAY, CORNWALL, TR9 6TT, UK -- Device Listing # D000745. --- Designed to reduce the levels of circulating leukocytes and remove microemboli greater than 40 microns in size from the perfusate during extracorporeal circulation including: gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    REF BB50T: Lots 326902, 402802, 405002;  REF BB50T-BULK: Lots 228702, 229902, 328202
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of MN, MO, OH, MA, NY, NJ, WY, AZ, CA, IL, LA, IN, CO, NC, and TX.
  • 제품 설명
    PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter. || The filters are individually packaged in a clear, plastic pouch with black writing - 50 per case, or in bulk packaged 100 filters/bag and two bags per shipper for a total of 200 filters/shipper.
  • Manufacturer