Events

Rappel de Device Recall QuikClot Trauma Pad

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 Z-Medica, 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
    79407
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0925-2018
  • Date de mise en oeuvre de l'événement
    2017-11-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162235
  • 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
    Dressing, wound, drug - Product Code FRO
  • Cause
    A customer complained that one of the pouches in a box of 10 had "quikclot roll" pouch instead of "quikclot traumapad" pouch. the carton as well as the remaining 9 pouches were properly identified as quikclot trauma pad. the customer alleged that when the pouch was opened, it contained a quikclot traumapad. all 10 pouches in the box had the correct part number, lot number, and expiration date for the prod uct (quikclot traumapad).
  • Action
    On November 22, 2017 an URGENT ADVISORY NOTICE was issued to customers stating the following: The QuikClot TraumaPad is packaged with 10 pouches in a carton. This lot may contain some pouches that incorrectly identify the product as QuikClot Roll. All pouches (identified as TraumaPad or Roll) are identified with the correct Part N umber (REF 460), Lot Number, and Expiration Date for QuikClot TraumaPad, and contain the QuikClot TraumaPad product. Please note that the labeling on the cartons is also correct and we believe that this only impacts a small num ber of pouches. In addition, QuikClot TraumaPad and QuikCot Roll have the identical ingredients, chemical composition, indications for use, packaging material and surface area. The only difference is that the QuikClot TraumaPad is a 12 inch x 12 inch, 3-ply pad and the QuikClot Roll is a 3 inch x 4 yard roll. Both products are equally effective in being used to stop bleeding. This was the result of an isolated operator error. Please note that actions have been taken to prevent this issue in the future and further corrective actions are under review. Ifyou have any inventory of this lot number, you may choose to use the prod uct as the correct prod uct is packaged into each pouch (only pouch labeling is incorrect). Ifyou chose to destroy the prod uct or have any questions regardi ng this matter, please contact us at the email and telephone number below.

Device

Device Recall QuikClot Trauma Pad
  • Modèle / numéro de série
    Part# 460, Lot# 7397
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Nationally
  • Description du dispositif
    QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries
  • Manufacturer
    Z-Medica, LLC

Manufacturer

Z-Medica, LLC
  • Adresse du fabricant
    Z-Medica, LLC, 4 Fairfield Blvd, Wallingford CT 06492-1857
  • Société-mère du fabricant (2017)
    Z-Medica Llc
  • Source
    USFDA