Events

Rappel de Receptal Canisters

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 Hospira 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
    66448
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2593-2016
  • Date de mise en oeuvre de l'événement
    2013-09-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122416
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notes supplémentaires dans les données
    Apparatus, suction, operating-room, wall vacuum powered - Product Code GCX
  • Cause
    Hospira has become aware of customers using the incorrect size receptal liners with their receptal canisters, e.G., 1.5 l liner, 2l liner or 3l liner with a 1l canister. it is possible that if an incorrectly sized liner is used with a different size canister the lid may not fit and the vacuum/suction will not be sufficient and/or consistent.
  • Action
    URGENT MEDICAL DEVICE RECALL letters dated September 10, 2013 were distributed to direct accounts notifying them of the recall. The letter requests that customers to ensure that they only use liners and canisters of corresponding sizes (e.g. a 1000mL liner with a 1000mL canister) and to only use Hospira components. The letter further advises customers of an ongoing recall of the 1000mL Receptal systems. Customers were requested to complete and return the attached reply form and to notify other healthcare providers within their organization.Customers who further distributed the Receptal systems were requested to forward the letter to their customers and to request that the contact Stericycle at 1-888-943-5175 (Monday - Friday, 8:00 AM - 5:00 PM, CST) to obtain a reply form.

Device

Receptal Canisters
  • Modèle / numéro de série
    43423-04-01 43423-04-11 43423-04-21 43445-04-01 43445-04-11 43449-04-01 43449-04-11 43496-04-01
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    *** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY), District of Columbia, Puerto Rico; *** FOREIGN: Australia, Canada, Costa Rica, Singapore, South Africa
  • Description du dispositif
    Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) || Canister, ATS, 2000, with Valve || 1) List Numbers 43449-01 and 43449-11; LIST NO. 43449 RECEPTAL CANISTER; CANISTER FOR REUSE, THROW AWAY LINER ONLY; DO NOT FILL 900 ABOVE LINE || 2) List Numbers 43423-01 and 43423-21; LIST NO. 43423; RECEPTAL CANISTER; CANISTER FOR REUSE; THROW AWAY LINER ONLY; 1400. || 3) List Numbers 43445-01 and 43445-11; LIST NO. 43445; RECEPTAL CANISTER; CANISTER FOR REUSE; THROW AWAY LINER ONLY; DO NOT FILL 1900 ABOVE THIS LINE. || 4) List Number 43496-01.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Adresse du fabricant
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    USFDA