Events

Rappel de Rigid Suction Canister

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 Medline Industries 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
    75128
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0352-2017
  • Date de mise en oeuvre de l'événement
    2016-08-10
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149428
  • 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
    Bottle, collection, vacuum - Product Code KDQ
  • Cause
    Risk of implosion when the rigid suction canister is subjected to excessive negative pressure during use.
  • Action
    Medline Industries, Inc. sent an Urgent Recall Immediate Action Required letter dated August, 23, 2016, and destruction form via first class mail to affected customers on August 17, 2016 and August 23, 2016. The firm recommended the following actions: REQUIRED ACTION: 1. Immediately check your stock for item number OR220 and OR230 with lot numbers beginning with 9961601xxxx through 9961604xxxx (listed on the original case packaging). Destroy all affected products. If the rigid canisters are NOT in the original case packaging, we are instructing you to destroy them and we will send replacements. 2.Please return the completed enclosed destruction form listing the quantity of product(s) destroyed. Even if you do not have any of this product please complete and return the form, as indicated on the destruction form. When we receive your completed destruction form your account will receive replacements. 3.If you are a distributor, promptly notify any of your customers that may have received affected product. If you have any questions, please contact 866-359-1704.

Device

Rigid Suction Canister
  • Modèle / numéro de série
    RIGID CANISTER 2000 cc and 3000 cc with product code OR220 and OR230. Affected Lot Numbers 9961601xxxx through 9961604xxxx
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the following states: CA , CO , FL , GA, GA , IL , MA, MA , MD , MI, MO , NC , NE , NJ , NY, NY , OH, OK , PA, TX and WA.
  • Description du dispositif
    Rigid Suction Canister 3000 CC and 2000 CC.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Adresse du fabricant
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4485
  • Société-mère du fabricant (2017)
    Medline Industries Inc.
  • Source
    USFDA