Events

Rappel de Device Recall Adult Divided Cannula end tidal C)2 sampling w/male luerlock connector

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 SALTER LABS.

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
    62272
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1898-2012
  • Date de mise en oeuvre de l'événement
    2012-05-30
  • Date de publication de l'événement
    2012-06-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110043
  • 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
    Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
  • Cause
    A complaint was received, and later verified, that product labeled as so-1296 with male luer lock connector actually contained product with a female luer lock connector.
  • Action
    The firm, Salter Labs, called their customers to discuss the recall and followed up with a "PRODUCT RECALL" letter dated May 29, 2012. The letter was distributed to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory and return any of the lots in their possession to Salter Labs; contact Salter Labs Customer Service at 1-800-235-4203 to arrange for return of the product, and complete and return the attached form/record via fax to: 661-854-6816 or Toll Free 1-800-628-4690. Should you have any questions, please contact Salter Labs at 1-800-235-4203.

Device

Device Recall Adult Divided Cannula end tidal C)2 sampling w/male luerlock connector
  • Modèle / numéro de série
    Salter Part Number SO-1296, Tri-Anium Part numaber: 301-P3600; Lot number: 032612.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: FL, IN, KS, PA and TX.
  • Description du dispositif
    Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. || 7 ft, oxygen tube, 7 ft. CO2 tube || RX only.For Single Patient Use only. || Distributed by Tri-Anium || Assembled in Mexico. || Usage: Delivery of Anesthesia.
  • Manufacturer
    SALTER LABS

Manufacturer

SALTER LABS
  • Adresse du fabricant
    SALTER LABS, 100 Sycamore Rd, Arvin CA 93203-2300
  • Source
    USFDA