Events

Rappel de Device Recall GasChex sterilization indicators

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 Propper Mfg Co 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
    48969
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2330-2008
  • Date de mise en oeuvre de l'événement
    2008-02-07
  • Date de publication de l'événement
    2008-09-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72429
  • 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
    Indicator, physical/chemical sterilization process - Product Code JOJ
  • Cause
    The firm discovered a production specification discrepancy that may cause the indicators to show an inaccurate result.
  • Action
    On 2/07/08, Propper Mfg. Co. sent URGENT: DEVICE RECALL letters (dated 2/07/08) to the direct consignees, informing them of the recall of the affected lots of Gas-Chex EO Indicator Strips. The letters also instructed them to: (1) check their inventory to determine if they have the recalled lots in stock; (2) discontinue use of the affected lots; (3) reprocess any unused packs that have been processed with the affected lots of Gas-Chex EO Indicator Strips with non-recalled lots or an alternative product from another supplier; (4) return the affected lots to Propper Manufacturing; (5) complete the enclosed form and return via fax to Propper Mfg. Propper Mfg. will send a postage-paid label and instruction for return of the product, and will ship replacement product as soon as possible. Propper also recommended that consignees review the risk associated with items that have been monitored with the subject chemical indicators although a sterilization cycle failure is unlikely due to equipment controls and other monitoring methods. For questions, please contact Propper at 1-800-832-4300 during regular business hours (9 am to 4:30 pm).

Device

Device Recall GasChex sterilization indicators
  • Modèle / numéro de série
    Reorder No. 269001; Lots 6081, 6043, 6021, 7042, and 7013
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Puerto Rico
  • Description du dispositif
    Propper short gas-chex EO sterilization indicators, 250 strips per box, Reorder No. 269001, Propper Manufacturing Co., Inc., Long Island City, N.Y. 11101
  • Manufacturer
    Propper Mfg Co Inc

Manufacturer

Propper Mfg Co Inc
  • Adresse du fabricant
    Propper Mfg Co Inc, 36-04 Skillman Avenue, Long Island City NY 11101-1730
  • Société-mère du fabricant (2017)
    Propper Manufacturing Co Inc
  • Source
    USFDA