Rappel de Monoswift

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 C P Medical, 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
    69373
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0140-2015
  • Date de mise en oeuvre de l'événement
    2014-09-22
  • Date de publication de l'événement
    2014-10-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2015-02-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    Suture, surgical, absorbable, polydioxanone - Product Code NEW
  • Cause
    Cp medical inc. is recalling five lots of monoswift pgcl [poly(glycolide-co-caprolactone)] absorbable surgical suture for failing to meet the minimum tensile strength as dictated by usp was not met over the length of the product's shelf life.
  • Action
    CP Medical Inc.notified their customers between September 23 through October 3, 2014, of the recall via telephone or e-mail and followed up with a certified letter. Customers were advised to discontinue sale and/or use of the recalled product and return all existing stock to CP Medical. CP Medical also requested their customers to notify their downstream customers of the recall and request they return any unused recalled product, as well as provide information to them regarding distribution of the product. Customers are being asked to fill out and return a questionnaire regarding the recalled product and contact CP Medical Customer Service Representative at 1-800-950-2763 for return authorization and shipping account number. All shipping costs including those from downstream customers will be paid for by CP Medical. Replacement product or credit will be provided.

Device

  • Modèle / numéro de série
    Product Lot Number (s) Code  L345; 130618-12. L346; 140304-14. L463; 130513-16. L923; 130729-17; 140127-02. L942; 140117-03; 140128-06.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution including the states of: AR, AZ, CA, FL, ME, MI, NE, OR, SC, and WA
  • Description du dispositif
    Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. It is an undyed, monofilament synthetic absorbable suture with needle size 3/0.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    C P Medical, Inc., 803 NE 25th Ave, Portland OR 97232-2304
  • Société-mère du fabricant (2017)
  • Source
    USFDA