Events

Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Arrow International Inc 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    68987
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0066-2015
  • 사례 시작날짜
    2014-08-06
  • 사례 출판 날짜
    2014-10-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129204
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Catheter, percutaneous - Product Code DQY
  • 원인
    The component supplier recalled their 0.9% sodium chloride injection usp bd posiflush sf saline flush syringe 10ml because some unit packages may exhibit open seals which impact package integrity and potentially product sterility.
  • 조치
    Arrow International sent an Urgent Medical Device Recall Notification letter, dated August 6, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine any affected product. Customers were instructed to remove the BD pre-filled saline syringe from the exterior of the packaging. To return the BD syringes, customers were instructed to complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service. A customer service representative will contact the customer with a Return Good Authorization (RGA) Number and will provide instructions for the return of producet to Arrow International. All customers were asked to complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507. Attn: Customer Service. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.

Device

Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC)
  • 모델명 / 제조번호(시리얼번호)
    Product Numbers: ASK-04001-VCUH, ASK-04510-MM3, ASK-05001-TSC, ASK-05052-QV, ASK-05052-SFL, ASK-05502-UWMC, ASK-05541-MS2, ASK-09804-SPH, ASK-09810-PCMH1, ASK-09903-ECL, ASK-09903-PCMH1, ASK-11142-MGH3, ASK-12703-MGH2, ASK-12703-SPH, ASK-15703-MH, ASK-15854-FAM ASK-17702-PJHH1, ASK-21142-HF2, ASK-21242-PCMH1, ASK-21242-SFM1,  ASK-21242-UVA3, ASK-29803-HF3, ASK-29803-MM, ASK-29803-MS, ASK-29903-UK, ASK-29903-UK, ASK-34041-PTG, ASK-34052-PTG, ASK-35052-PTG, ASK-42703-AMC, ASK-42703-OHU1, ASK-42703-PCCH1, ASK-42703-PCSJ, ASK-42703-PPMC, ASK-42703-PSBM, ASK-42703-PSCH, ASK-42703-PSFM, ASK-42703-PTRH, ASK-42703-SJMT, ASK-42703-UHC, ASK-42802-ECL1, ASK-42802-PMCG, ASK-42802-PUCS, ASK-42854-CMC2, ASK-45703-MM2, ASK-45703-NYU1, ASK-45703-PCCH1, ASK-45703-PCHS1, ASK-45703-PCSJ, ASK-45703-PDCH, ASK-45703-PGBM1, ASK-45703-PHCH, ASK-45703-PHF, ASK-45703-PHF1, ASK-45703-PHPA2, ASK-45703-PIA, ASK-45703-PLGH1, ASK-45703-PMHG, ASK-45703-PSA, ASK-45703-PTMC, ASK-45703-PUAB, ASK-45703-PUC ASK-45703-PUHC, ASK-45703-PUR, ASK-45703-PVCU, ASK-45703-UHC, ASK-45703-UKM, ASK-45802-PCMH1, ASK-45854-NG, ASK-45854-PCHS1, ASK-45854-PECL, CDC-02041-MK1A, CDC-05041-HPK1A, CDC-05052-HPK1A,  CDC-21242-X1A, CDC-24703-X1A, CDC-25123-X1A, CDC-25402-X1A, CDC-25502-X1A, CDC-25553-X1A, CDC-26553-X1A, CDC-29803-X1A, CDC-29903-X1A CDC-34052-HPK1A, CDC-35041-VPS, CDC-35052-HPK1A, CDC-35052-VPS,  CDC-35063-VPS, CDC-35563-VPS, CDC-42703-XP1A, CDC-42802-XP1A, CDC-42802-XP1A, CDC-44041-HPK1A, CDC-44052-HPK1A, CDC-45041-HPK1A, CDC-45041-VPS, CDC-45541-HPK1A, CDC-45541-VPS, CDC-45552-HPK1A, CDC-45703-XP1A, CDC-45703-XPB1A, CDC-45802-XP1A, CDC-45854-XP1A,  CDC-46702-XP1A, with lot numbers: 23F13H1030, 23F13H0046,RF3053077, 23F13J0406, 23F13H0230, 23F13J0435, 23F13J0440, 23F13H1031, 23F13J0181, 23F13G0409, 23F13H0060, 23F13H0231, RF3053088, 23F13H0232, 23F13H0062,  23F13H0233, RF3053092, RF3053096, 23F13J0072, 23F13H0520, 23F13H1032, 23F13H0064, 23F13J0446, 23F13H0804, 23F13J0187, 23F13H0069, 23F13J0193, 23F13H1033, 23F13G0724, 23F13H0898, RF3053035, 23F13J0202, 23F13H0297, RF3053111, 23F13H0521, 23F13G0402, 23F13G0404, 23F13H1034, 23F13G0495, 23F13J0399, 23F13H0072, 23F13H0808, 23F13H0810, 23F13H0313, RF3053655, 23F13J0208, 23F13H0315, 23F13H0768, 23F13J0254, RF3052973, 23F13J0204, 23F13J0037, 23F13J0352, 23F13J0207, 23F13H0687, 23F13H0512, 23F13J0349, 23F13J0452, RF3040503, 23F13G0472, RF3052873, 23F13J0400, 23F13J0401, 23F13H0816, 23F13H0817, 23F13H0818, 23F13J0241, 23F13H0451, 23F13H0861, 23F13H0858, 23F13H0819, 23F13G0830, 23F13H0519, 23F13H0821, 23F13J0351, 23F13G0473, 23F13J0217, 23F13J0073, RF3065022, 23F13H0045, 23F13H0916, 23F13H0796, 23F13J0403, 23F13J0542, 23F13H0127, 23F13J0454, 23F13J0057, 23F13J0291, 23F13J0080, 23F13J0076, 23F13H0994, 23F13H0013, 23F13H0993,  23F13H0022, RF3064650, 23F13H0919, 23F13J0160, 23F13H1018, 23F13J0162, 23F13J0166, 23F13H0911, RF3052890, 23F13J0167, RF3052884, RF3052536, RF3041482, 23F13J0178, RF3054066, 23F13J0135, 23F13J0014, 23F13H0349, 23F13H0351, 23F13H0266, 23F13H0036, 23F13H0265, 23F13H0707, 23F13H0709, 23F13H0941, 23F13J0319, 23F13J0133, 23F13J0390, 23F13J0137, 23F13G0578, 23F13J0331, 23F13H0750, 23F13H0267, 23F13H0752, 23F13H0753, 23F13J0304, 23F13J0298, 23F13J0301, 23F13H0751, 23F13J0303, 23F13G0217, 23F13H0268, 23F13H0269, 23F13H0270, RF3052159, RF3054123, RF3054125, 23F13H0759, 23F13J0249, 23F13H0668, 23F13H0664, 23F13H0706.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
  • Manufacturer
    Arrow International Inc

Manufacturer

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