Events

Rappel de Bard Access

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 Bard Access Systems.

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
    70430
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1273-2015
  • Date de mise en oeuvre de l'événement
    2014-08-08
  • Date de publication de l'événement
    2015-03-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133938
  • 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
    Set, administration, intravascular - Product Code FPA
  • Cause
    Some unit packages of bd posiflush sf saline flush syringe 10 ml may exhibit open seals, which could impact product sterility. bard includes these pouched syringes, attached to some configurations of picc kits, port access kits (pak), powerglide kits, midline kits, and convenience kits.
  • Action
    The firm, BD Medical, sent an "URGENT VOLUNTARY PRODUCT RECALL" letter dated July 22, 2014 and a follow-up "URGENT: Voluntary Product Recall-BD PosiFlush SF Saline Flush Syringe 10mL with rework instructions for applicable Bard Kits" letter dated August 8, 2014 to its customers and distributors. The letters described the product, problem and actions to be taken. The customers were instructed to immediately review your inventory and quarantine product subject to the recall; complete and return the Recall Response Card form via fax to BD at 1-201-847-6990 or email to Becky_Saggau@bd.com and return all affected products. Note: If you do not have any of the affected lots in your inventory, please complete the Recall Response Card form indicating you have (0) quantity and fax or email. The distributors were instructed to immediately examine your inventory and identify any product subject to this notification. In addition, if you have further distributed this product, please identify your customers and notify them at once of this notification. Complete the attached Recall Reply Form and FAX to Bard Access Systems, Inc. at 1-801-522-5674, or EMAIL to BASD.fieldaction@crbard.com. Even if you do not have any inventory of the affected syringe lots. Please direct any return requests and questions to our coordinator at 800-290-1689. If you have any questions or require assistance with the return of the recalled product and/or availability of replacement product, please contact BD Customer Service at 1-888-237-2762 option 3.

Device

Bard Access
  • Modèle / numéro de série
    Lot Numbers: REXE0073, REXD0494, REYF0446, REXE0074, REXE0090, REYE1239, REXD1915, REXD2151, REXD2152, REYE1275, REYF0305, REXD2142, REYE1697, REXE0082, REYE1240, REYE0972, REXE0083, REXE0072, REXE0095, REYE1276, REXE0081, REYE1267, REYE1568, REXD1616, REXE0087, REYE1232, REYE1567, REXE0092, REXE0094, REYE1585, REXD1936, reye0216, REYE1707, REYE1270, REXE0075, REYF0303, reyd1639, REXE0084, REXE0088, REYE1566, REXD1918, REYE1266, REXE0091, REYE1694, REXD1930, REYE1231, REXD2153, REXD2154, REXE0076, REYE1693  Product codes: PA-0029, PA-0029YN, PA-0030, PA-0031, PA-0031YN, PA-0032, PA-0032YN, PA-0033, PA-0033YN, PA-0034, PA-0034YN, PA-0038, PA-0038YN, 2632010, 2632034, 2632210, 2632234, 2681910, 2682010, 2682034, 2682215, 2682234, 2131910, 2131975, 2132075, 2141910, 2142010, 2142075, 2142210, 2142275
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution.
  • Description du dispositif
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G x 1 in , SafeStep Port Access Kit 20G x 0.75in , SafeStep Port Access Kit 20G x 0.75in with Y-Site, SafeStep Port Access Kit 20G x 1 in , SafeStep Port Access Kit 20G x 1 in with Y-Site, SafeStep Port Access Kit 19G x 0.75in , SafeStep Port Access Kit 19G x 0.75in with Y-Site, SafeStep Port Access Kit 19G x 1 in , SafeStep Port Access Kit 19G x 1 in with Y-Site, SafeStep Port Access Kit 20G x 1.5in , SafeStep Port Access Kit 20G x 1.5in with Y-Site, MiniLoc Port Access Kit 20G x 1 in, MiniLoc Port Access Kit 20G x 0.75in, MiniLoc Port Access Kit 22G x 1 in, MiniLoc Port Access Kit 22G x 0.75in, MiniLoc Port Access Kit 19G x 1 in with Y-Site, MiniLoc Port Access Kit 20G x 1 in with Y-Site, MiniLoc Port Access Kit 20G x 0.75in with Y-Site, MiniLoc Port Access Kit 22G x 1.5in with Y-Site, MiniLoc Port Access Kit 22G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 19G x 1.0 in with Y-Site, PowerLoc Max Port Access Kit 19G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 20G x 0.75in with Y-Site, PowerLoc Max Port Access Kit 19G x 1.0 in , PowerLoc Max Port Access Kit 20G x 1.0 in , PowerLoc Max Port Access Kit 20G x 0.75in , PowerLoc Max Port Access Kit 22G x 1.0 in , PowerLoc Max Port Access Kit 22G x 0.75in || The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
  • Manufacturer
    Bard Access Systems

Manufacturer

Bard Access Systems
  • Adresse du fabricant
    Bard Access Systems, 605 N 5600 W, Salt Lake City UT 84116-3738
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA