Events

Rappel de Device Recall CBC II Wound Drains

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 Stryker Instruments Div. of Stryker Corporation.

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
    70841
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1565-2015
  • Date de mise en oeuvre de l'événement
    2015-03-26
  • Date de publication de l'événement
    2015-05-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135089
  • 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, single patient use, portable, nonpowered - Product Code GCY
  • Cause
    Stryker instruments is voluntarily recalling the cbcii wound drains and ambulating bulb for a potential sterility breach in the packaging.
  • Action
    An URGENT MEDICAL DEVICE NOTIFICATION letter was sent to all customers on 03/31/2015. The letter identified the affected product, the reason for the recall, the risk to health, and actions to be taken by the customer or user. All are asked to sign the Business Reply Form stating they have read the Notification and followed all instructions within. Customers were asked to immediately check all inventory and quarantine any affected product, return affected product to Stericycle for destruction using a return label provided by Stericycle. Upon receipt of affected product a credit will be issued to customer account.

Device

Device Recall CBC II Wound Drains
  • Modèle / numéro de série
    Part Number: 0215-018-200 and lot numbers: 10082012 10266012 11089012 11222012 12047012 12240012 13121012 14034012 10099012 10289012 11109012 11231012 12059012 12256012 13145012 14072012 10105012 10309012 11122012 11241012 12072012 12283012 13156012 14083012 10118012 10319012 11129012 11252012 12080012 12319012 13194012 14164012 10134012 10323012 11136012 11271012 12125012 12332012 13235012 14170012 10168012 10342012 11143012 11305012 12144012 12349012 13260012 14234012 10180012 11012012 11151012 11337012 12152012 13015012 13275012 10217012 11035012 11168012 11355012 12157012 13039012 13317012 10229012 11052012 11188012 12004012 12178012 13057012 13343012 10256012 11070012 11199012 12027012 12198012 13086012 14016012
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution. US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.
  • Description du dispositif
    1/8 in. Double Trocar with Wound Drain || Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Adresse du fabricant
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA