Events

Rappel de Device Recall Polyglycolic Acid (PGA) Absorbable Suture

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
    60173
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0260-2012
  • Date de mise en oeuvre de l'événement
    2009-01-02
  • Date de publication de l'événement
    2011-11-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104676
  • 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, absorbable, synthetic, polyglycolic acid - Product Code GAM
  • Cause
    The seal integrity of the outer product pouch may be compromised due to partial delamination of the two layers that make up part of the pouch.
  • Action
    CP Medical, Inc. sent a "RECALL NOTICE" letter dated January 5, 2009 to all affected customers.The letter describes the product, problem, and the actions to be taken by the customers. Customers are instructed to identify affected product and to return the product to the firm. Customers should call 1-503-232-1555 for a return goods authorization number and shipping account number. Contact your customer service representative at 1-800-950-2763 for questions concerning this recall.

Device

Device Recall Polyglycolic Acid (PGA) Absorbable Suture
  • Modèle / numéro de série
    398A and 453A
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Product is a synthetic absorbable suture with needle and labeled as sterile. The product is sealed inside an inner foil pouch with an outside Tyvek pouch. The outer sterile barrier seal is intact. The product is boxed and shrink wrapped for protection against contamination. || The product is a Violet, monofilament synthetic absorbable suture with needle, size 3/0 (2.0 Metric), NFS-2 Needle (Product code 398A-Polyglycolic Acid) or size 2/0 (3.0 Metric) NFS-1 Needle. (Product code 453A-Polyglycolic Acid). || Product is labeled in part: "***NFS-1***CUTTING***Coated POLYGLYCOLIC ACID Violet (PGA) Braided Absorbable Suture STERILE***Manufacturer CP Medical***". || Intended for use in general soft tissue approximation and/or ligation including use in pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. The suture is not recommended for adult cardiac tissue, microsurgery or neural tissue. The absorbable sutures are useful where extended wound support is desirable.
  • 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