Events

Rappel de Device Recall MediVac(TM) Flex Advantage(TM) Suction Canister Liner

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 Cardinal Health 200, LLC.

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
    79702
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1546-2018
  • Date de mise en oeuvre de l'événement
    2018-03-28
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163108
  • 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
    Apparatus, suction, operating-room, wall vacuum powered - Product Code GCX
  • Cause
    Products may be missing a one-way valve on the fluid patient port.
  • Action
    Cardinal Health sent an Urgent Product Recall letter dated March 28, 2018, Please take the following actions: 1. INSPECT your inventory for the affected product code and lot number (listed on package) 2. SEGREGATE and QUARANTINE all on-hand product 3. RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652- 9648, whether or not you have affected product, indicating the product code, lot and quantity of product you've quarantined 4. CONTACT Customer Service at 800-964-5227 to arrange for return and credit of any affected product . For further questions, please call (800) 292- 9332.

Device

Device Recall MediVac(TM) Flex Advantage(TM) Suction Canister Liner
  • Modèle / numéro de série
    a) REF 6561-910C, Lot Numbers: J802-384, J802-391 b) REF 6561-916K, Lot Number: J802-386 c) REF 6561-920C, Lot Number: J802-396
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the state of MA
  • Description du dispositif
    Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: || a) REF 6561-910C || b) REF 6561-916K || c) REF 6561-920C || To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in operating rooms but are also used outside the surgical field as well as post-operatively within patient suites. The collection containers hold the fluids until they are ready for proper disposal. Sources of vacuum range from wall suction (central vacuum piped throughout the healthcare facility) to liposuction devices (portable suction pumps).
  • Manufacturer
    Cardinal Health 200, LLC

Manufacturer

Cardinal Health 200, LLC
  • Adresse du fabricant
    Cardinal Health 200, LLC, 3651 Birchwood Dr, Waukegan IL 60085-8337
  • Société-mère du fabricant (2017)
    Cardinal Health
  • Source
    USFDA