Events

Rappel de Device Recall Stryker Flyte (surgical gown system)

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
    70332
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1077-2015
  • Date de mise en oeuvre de l'événement
    2014-12-22
  • Date de publication de l'événement
    2015-02-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-05-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133146
  • 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
    Gown, surgical - Product Code FYA
  • Cause
    A single lot (11121171) of flyte toga peel-away x-large (catalog number 0408-830-100) was labeled with an incorrect expiration date of 2412-12-01. the correct expiration date should have read 2014-12-01.
  • Action
    Stryker sent an Urgent Medical Device Recall Notification letter dated December 22, 2014, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and responding to the formal recall notification. Customers were instructed to do the following: 1. Immediately review this Recall Notification 2. Immediately check all stock areas and/or operating room storage and quarantine any affected product found. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in their inventory. Complete and return the BRF even if they do not have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in this Notification. 4. If customers further distributed this product, they were instructed to forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF. Completed Business Reply Forms should be faxed to 866-521-2762. Upon receipt of the Business Reply Form, Stryker will email a pre-paid shipper. This shipper can be used to return the recalled Flyte Toga(s) to Stryker. Upon receipt of the recalled Flyte Toga(s), credit will be applied to the customer's account. For questions regarding this recall customers were instructed to contact Stryker Instruments: Monday-Friday 8am-5pm (EST) at 269-389-2458. For questions regarding this recall call 269-389-2458.

Device

Device Recall Stryker Flyte (surgical gown system)
  • Modèle / numéro de série
    Part/Catalog number: 0408-830-100 Lot number: 11121171 Expiration date (as printed): 2412-12-01
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AL, AR, AZ, IA, IL, IN, LA, MA, NC, NE, NM, SC, TN, TX, WI, and WV.
  • Description du dispositif
    Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and Classification System (PB70:2012).
  • 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