Events

Rappel de Device Recall Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits

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
    55385
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1682-2010
  • Date de mise en oeuvre de l'événement
    2010-03-29
  • Date de publication de l'événement
    2010-05-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90745
  • 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
    Peripherally Inserted Central Catheter - Product Code LJS
  • Cause
    Tight fit in sheath. arrow has received complaints of the picc catheter fitting too tightly in the "kit supplied" peelable sheath. in some cases, clinicians have been unable to insert the catheter through the peelable sheath during the insertion procedure. if the catheter will not pass through the sheath, the clinician is required to place a guide wire back into the sheath, remove the sheath, a.
  • Action
    Arrow International issued an Urgent Medical Device Recall letter dated 3/29/10 to inform their customers of the problem and the need to return the product.

Device

Device Recall Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits
  • Modèle / numéro de série
    Product number ASK-01451-BMH - Lot numbers RF8060214 and RF8096394; Product number ASK-05041-CHC - Lot numbers RF8109279 and RF9056727; Product number ASK-05041-CHC1 - Lot numbers RF9069677 and RF9098408; Product number ASK-05041-CHM - Lot numbers RF8057827 and RF8068899; Product number ASK-05041-HMC - Lot numbers RF8068662, RF8083994, RF8108545, RF9043625, RF9056403, RF9085278, and RF9098580; Product number ASK-05041-QV - Lot number RF9097395; Product number ASK-07041-BMH - Lot numbers RF9031839, RF9098784, and RL8108648; Product number CN-05041-LW - Lot numbers RF8069608, RF9056127, RF9070920, and RL9019402; Product number MSO-01451-UCL - Lot numbers RF9057410, RF9084460, RL8118758, and RL9029477; Product number MTO-01451-RH - Lot number RL9019228; Product number PL-05041 - Lot numbers RF8071766 and RF9109677; Product number PR-04041-HPX - Lot numbers RF8072920 and RF8109646; Product number PR-05041 - Lot numbers RF8056742, RF8068423, RF8069651, RF8071677, RF8095208, RF8095832, RF8108465, RF9028902, RF9043449, RF9056132, RF9085152, and RF9086357; Product number PR-05041-HP - Lot numbers RF8072840, RF8083506, RF8084926, and RF8107907; Product number PR-05041-HPX - Lot numbers RF8071099, RF8072981, RF9015967, RF9057607, and RF9097057; Product number PR-05041-LW - Lot numbers RF8057252, RF8072743, RF8083529, RF8108466, RF8110585, RF9031472, RF9044054, RF9060502, and RF9097058; Product number PR-05041-MW - Lot numbers 8057253, RF8060216, RF8095834, RF8108467, RF8110586, RF9016412, RF9031473, RF9044055, RF9069045, RF9071244, RF9085152, RF9086354, RF9100412, and RF9109679; Product number PR-05041-T - Lot numbers RF8068845 and RF8107962; Product number PR-05042 - Lot numbers RF8068846, RF8107963, RF8122680, RF9016413, RF9044057, and RF9073297; Product number PR-05541-HPX - Lot number RF8124014; Product number PR-07041-PTSP - Lot numbers RF8068850, RF8071679, RF8107965, RF8110358, RF9042708, and RF9072922; and Product number RJ-01451-W - Lot numbers RF8068664, RF8096774, RF8123596, and RF9060298.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA, Australia, Brazil, Canada, New Zealand, Hong Kong, Malaysia, and Chile.
  • Description du dispositif
    Arrow 4FR Peripherally Inserted Central Catheter (PICCs) Kits. Product numbers: ASK-01451-BMH; ASK-05041-CHC; ASK-05041-CHC1; ASK-05041-CHM; ASK-05041-HMC; ASK-05041-QV; ASK-07041-BMH; CN-05041-LW; MSO-01451-UCL; MTO-01451-RH; PL-05041; PR-04041-HPX; PR-05041; PR-05041-HP; PR- 05041-HPX; PR-05041-LW; PR-05041-MW; PR-05041-T; PR-05042; PR-05541-HPX; PR-07041-PTSP; and RJ-01451-W.
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Adresse du fabricant
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA