Events

Rappel de Device Recall Perifix FX Epidural Anesthesia Tray

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 B. Braun Medical, 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
    78878
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0571-2018
  • Date de mise en oeuvre de l'événement
    2017-06-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-04-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160788
  • 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
    Needle, hypodermic, single lumen - Product Code FMI
  • Cause
    B. braun medical inc. (bbmi) initiated this recall of various bbmi convenience kits containing the 22ga 1-1/2in safetyglide needle due to the presence of loose polypropylene foreign matter was above release specification. this foreign matter has been identified as a product hub material which has been tested for biocompatibility per iso 10993 during the product development process.
  • Action
    The firm, BD, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 6/12/2017 to its customers/kit packers. B.Braun Medical Inc. (BBMI), sent a "VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" letter dated 6/23/2017 to all BBMI customers in receipt of suspect product. Customers were notified by US Postal Service Certified Mail with registered return receipt mail or FedEx Priority. The letters described the product, problem and actions to be taken. The customers were instructed to review the device notification in its entirety and inform all users of the recall; determine your inventory of the affected product-Do not destroy any affected product; complete and return the "Product Removal Acknowledgement" form to B.Braun Medical Inc. Quality Assurance department via fax to 610-849-1197 or email to PA_QualityAssurance.BBMUS_Service@bbraun.com within two 2 weeks of receipt, even if the total inventory in your possession is zero 0; and if you have any full cases, partial cases or unused individual pieces a BBMI Customer Support Representative will contact you to provide instructions for handling affected product and arrange for return. Should you have any questions or concerns regarding the recall, please contact our Customer Support Department at 800-227-2862.

Device

Device Recall Perifix FX Epidural Anesthesia Tray
  • Modèle / numéro de série
    0061482582. 0061509281. 0061523764. 0061539142. 0061541519. 0061545624. 0061549251. 0061523766. 0061536442. 0061549079. 0061525251. 0061536434. 0061534703. 0061480989. 0061486228. 0061519902. 0061523684. 0061530885. 0061536042. 0061539966. 0061546081. 0061550336.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution.
  • Description du dispositif
    Perifix FX Epidural Anesthesia Tray. Product Catalog Numbers: 551993, 552051, 552083, 552119, 555569. || Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
  • Manufacturer
    B. Braun Medical, Inc.

Manufacturer

B. Braun Medical, Inc.
  • Adresse du fabricant
    B. Braun Medical, Inc., 901 Marcon Blvd, Allentown PA 18109-9512
  • Société-mère du fabricant (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA