Events

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
    68153
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1708-2014
  • Date de mise en oeuvre de l'événement
    2014-04-23
  • Date de publication de l'événement
    2014-06-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127056
  • 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 one lot of monoswift pgcl [poly (glycolide-co-caprolactone)] absorbable sutures for failing to meet the usp minimum average value for knot pull (tensile) strength.
  • Action
    CP Medical, Inc., sent a Recall Notice letter dated April 28, 2014 to affected customers. The letter identified the affect product, problem and actions to be taken. The letter instructed customers to immediately discontinue selling or using the recalled product and return all existing stock to CP Medical. They also request their customers to contact downstream customers and request that all their existing stock be returned. CP Medical, Inc. asks all customers to provide them with information as to the quantity of recalled product they are able to return and for all stock they are not able to recover, customers are asked to provide quantity information and location of the product for accountability purposes. The firm requests that all customers contact their customer service representative at 1-800-950-2763 for a Return Goods Authorization (RGA) # and shipping account number. All shipping costs, including those from customers, will be paid for by CP Medical. Replacement product (at no cost) will be provided.

Device

Monoswift
  • Modèle / numéro de série
    Lot 130826-08, expiration 2015-07.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide
  • Description du dispositif
    Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. 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 (2.0 metric), PS-1 Needle
  • Manufacturer
    C P Medical Inc.

Manufacturer

C P Medical Inc.
  • Adresse du fabricant
    C P Medical Inc., 803 NE 25th Avenue, Portland OR 97232-2304
  • Source
    USFDA