Events

Rappel de Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC)

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Arrow International Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    68987
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0066-2015
  • Date de mise en oeuvre de l'événement
    2014-08-06
  • Date de publication de l'événement
    2014-10-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-10-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129204
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Catheter, percutaneous - Product Code DQY
  • Cause
    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.
  • Action
    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)
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    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
  • Adresse du fabricant
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA