Events

Rappel de Device Recall Gyrus ACMI Disposable FalopeRing Band Applicator 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 Gyrus 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
    67578
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1196-2014
  • Date de mise en oeuvre de l'événement
    2014-02-19
  • Date de publication de l'événement
    2014-03-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-04-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125747
  • 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
    Device, occlusion, tubal, contraceptive - Product Code KNH
  • Cause
    Due to an anomaly in the packaging process for specific lots of disposable falope-ring band kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. the breach may or may not be easily seen.
  • Action
    Olympus sent an Urgent Medical Device Recall letter dated February 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Olympus requires you to take the following action: I. Immediately cease any further use of any affected product you have, remove it from your inventory and quarantine it until it is shipped back to us. 2. Call your Olympus customer service representative at 1-888-524-7266 to obtain a Returned Goods Authorization so that you may return the product with no charge to you. Olympus will issue a credit t or replacement to your facility y for any returned product. 3. Please note on the enclosed questionnaire that you have received this information. 4. Fax the completed questionnaire to 484-896-7128 regardless of whether you have any affected inventory at your facility. ln addition, if you may have further distributed this product, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter.

Device

Device Recall Gyrus ACMI Disposable FalopeRing Band Applicator Kits
  • Modèle / numéro de série
    Lots: MK761655, MK764022, MK767655, MK526401
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution.
  • Description du dispositif
    Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. || The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).
  • Manufacturer
    Gyrus Medical, Inc

Manufacturer

Gyrus Medical, Inc
  • Adresse du fabricant
    Gyrus Medical, Inc, 6655 Wedgwood Rd N Ste 160, Osseo MN 55311-3613
  • Société-mère du fabricant (2017)
    Olympus Corporation
  • Source
    USFDA