Events

Rappel de Rifton Toddler Chair

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 Community Products, LLC.

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
    49572
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0318-2009
  • Date de mise en oeuvre de l'événement
    2008-09-12
  • Date de publication de l'événement
    2008-12-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-03-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73829
  • 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
    Toddler Chair - Product Code INN
  • Cause
    Some hip straps were assembled incorrectly by threading the buckle on the strap upside down. if a child were left unattended in spite of the warnings on the product and in the manual, a defective hip strap could loosen, allowing the child to slip down in the chair and this could create a choking hazard.
  • Action
    On 9/12/08, Rifton Equipment began notifying the customers by phone using a phone script. This phone call notified the customers of the recall and also served as an effectiveness check that they were notified. The customers were instructed to remove the product from use until the replacement kit is received and the old strap is returned. The replacement kit contains instructions with ID codes and a place for the customer to verify that they have made the replacement as instructed. It also contains the required number of new hip straps. A verification check was sent with the replacement straps, which the customer will sign and return to the firm verifying that they have replaced the straps for the affected serial numbers. Rifton Equipment is providing the customer with return shipping labels which were sent by UPS 2nd day air. The replacement straps use black thread instead of tan thread for the sewing on the ends of the straps so that the firm can be sure that the returned straps are not the new replacement straps. For questions or additional information, contact Rifton Equipment at 1-800-571-8198.

Device

Rifton Toddler Chair
  • Modèle / numéro de série
    Serial Numbers: E77020080701AE, E77020080701AF, E78020080703AB, E78020080703AC, E77020080701AC, E78020080703AD, E77020080701AD,  E77020080701AA, E77020080701AB, E76020080704AA, E78020080704AA,  E77020080704AE, E77020080704AA, E77020080704AB, E77020080704AC, E78020080703AA, E78020080705AB, E78020080705AA, E76020080709AB, E78020080709AA, E76020080709AA, E78020080709AB, E77020080709AA,  E77020080709AB, E77020080709AC, E77020080709AD, E78020080712AD, E77020080711AA, E77020080712AA, E77020080709AE, E78020080711AB, E78020080712AC, E76020080712AA, E78020080711AA, E78020080712AA, E78020080712AB, E77020080704AD, E78020080715AD, E76020080716AC, E77020080716AF, E78020080715AE, E78020080715AF, E78020080715AG, E78020080716AA, E76020080716AB, E77020080716AA, E77020080716AB, E78020080716AC, E76020080716AA, E78020080716AB, E77020080714AA, E77020080714AB, E77020080714AC, E77020080714AD, E77020080714AE, E78020080707AA, E78020080715AA, E78020080715AB, E78020080715AC,  E78020080719AA, E77020080716AC, E77020080716AD, E76020080722AA, E78020080719AB, E78020080723AA, E77020080723AB, E77020080723AA, E78020080722AA, E77020080722AA, E77020080723AC, E77020080723AD, E77020080716AE, E77020080716AG, E78020080724AD, E78020080724AE,  E78020080724AB, E76020080723AA, E77020080723AE, E78020080724AA, E77020080724AA, E78020080724AC, E78020080723AB, E78020080723AC, E77020080724AB, E77020080725AC, E78020080725AA, E77020080725AA,  E77020080725AB, E78020080728AB, E77020080728AA, E78020080728AA,  E76020080730AA, E77020080730AA, E76020080730AB, E77020080731AB, E78020080802AB, E77020080802AD, E78020080802AA, E78020080802AC, E78020080801AB, E77020080802AB, E77020080802AC, E78020080801AC,  E77020080801AF, E77020080801AA, E78020080716AD, E78020080801AA, E78020080802AD, E77020080801AB, E77020080801AC, E77020080801AD,  E77020080801AE, E77020080804AA, E78020080802AE, E77020080804AC, E78020080804AB, E78020080804AA, E77020080804AB, E77020080806AA, E76020080731AA, E77020080731AA, E77020080802AA, E77020080809AA,  E77020080809AB, E78020080806AF, E77020080806AB, E78020080806AA, E77020080809AC, E78020080809AC, E78020080809AA, E78020080806AB, E78020080806AC, E78020080806AD, E78020080806AE, E78020080809AB,  E76020080809AA, E76020080811AA, E77020080811AA, E78020080812AA, E78020080812AB, E78020080812AC, E78020080812AD, E78020080812AF, E78020080811AA, E78020080812AE, E78020080812AG and E78020080812AH. The code is located underneath the seat of the chair.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution including USA and countries of Spain and Great Britain.
  • Description du dispositif
    Toddler Chair Hip Strap (Belt). The hip belt is made with nylon webbing and a plastic buckle. 510(k) exempt, Medical Device Listing # R061877. || The product is used as a hip strap chair for children.
  • Manufacturer
    Community Products, LLC

Manufacturer

Community Products, LLC
  • Adresse du fabricant
    Community Products, LLC, 2032 Route 213, Rifton NY 12471
  • Société-mère du fabricant (2017)
    Community Products Llc
  • Source
    USFDA