Events

Rappel de Device Recall Vinyl PowderFree Exam Gloves

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 Gulf South Medical Supply 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
    63603
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0295-2013
  • Date de mise en oeuvre de l'événement
    2012-06-20
  • Date de publication de l'événement
    2012-11-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-08-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114353
  • 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
    Glove, Patient Examination Vinyl - Product Code LYZ
  • Cause
    Gulf south medical supply recalled their select medium and large size vinyl exam gloves because they were inadvertently shipped prior to u.S. customs clearing them for sale.
  • Action
    The firm, PSS World Medical, sent an "URGENT RECALL NOTICE" dated June 20, 2012 via USPS to all customers that received the product. The notice described the product, problem and actions to be taken. The customers were instructed to examine their inventory, quarantine the affected lot numbers listed in this recall and return the product; If the product was further distributed, to inform their customers of the recall and request they return the affected product directly to them; and contact their Gulf South Customer Care team via telephone at 1-800-347-2456 or email to customercare@gsms.com to request a return goods authorization. If you have any questions, contact the Product Integrity Leader Quality Assurance at 904-380-4501.

Device

Device Recall Vinyl PowderFree Exam Gloves
  • Modèle / numéro de série
    Lot # (for both sizes) 030212BU216995995 Medium gloves are Model # 6370, Product # 802634 Large gloves are Model # 6371, Product # 80635.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: DE, KY, LA, MD, NJ, NY, PA, TX, VA, and WV.
  • Description du dispositif
    Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. || Usage: Patient Examination.
  • Manufacturer
    Gulf South Medical Supply Inc

Manufacturer

Gulf South Medical Supply Inc
  • Adresse du fabricant
    Gulf South Medical Supply Inc, 4345 Southpoint Blvd, Jacksonville FL 32216-8013
  • Source
    USFDA