Events

Rappel de Polybond

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.

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
    37756
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0807-2007
  • Date de mise en oeuvre de l'événement
    2007-04-03
  • Date de publication de l'événement
    2007-05-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-08-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51466
  • 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 - Product Code GAT
  • Cause
    Potential for sterility of product to be compromised. suture package seals incomplete or missing.
  • Action
    On 04/03/2007 the firm notified its Polyester product (Polybond) customer by telephone and followed up on 04/09/2007 with a letter via certified mail requesting the distributor to discontinue sales of the affected product lot, to notify their customers of the issue, and return stock to CP Medical. The firm provided the distributor with a letter dated 04/09/2007 to be provided to the distributor's customers requested those customers to discontinue use of the affected product lots and return stock to their distributor who in turn are to return product to CP Medical. On 04/20/2007 the firm notified its Polypropylene and Polydioxanone product customers by letter dated 04/17/2007 via certified mail requesting distributors to discontinue sales of the affected product lot, to notify their customers of the issue, and return stock to CP Medical. The firm provided the distributor with a letter dated 04/18/2007 to be provided to the distributor's customers requested those customers to discontinue use of the affected product lots and return stock to their distributor who in turn are to return product to CP Medical.

Device

Polybond
  • Modèle / numéro de série
    Product label is coded CP523A. Lot numbers include: I0625120 expiration 2011-08, and I0627120-01 expiration 2011-08.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Firm distributes products to human and veterinary medical device distribution centers worldwide. Polybond Polyester sutures, product CP523A, were distributed to one distribution center in South Africa. Polypropelene sutures, product 8665, were distributed to veterinary distribution centers in OH, OR, and NE for nationwide distribution. Polydioxanone sutures, product M398A, were distributed to human and veterinary distribution centers in AZ, IA, OH, LA, MA, MI, MO, NE, and TX for nationwide distribution.
  • Description du dispositif
    Product is an EO Sterile, Polyester braided and coated nonabsorbable surgical suture with double needle, size 2/0 (3.0 Metric), NSH 26 mm TAPER Needle. Product is wrapped in a five-fold card with inserted flap ends (overwrap). A label is placed on the overwrap and the packet is then inserted into a tyvek/mylar pouch. One end of the overwrap card is printed with 'Open'. This end is positioned in the pouch so it is closest to the peel-open end. No suture is exposed or visible through the overwrap which must be torn to have access to the suture and needle. Product is boxed (12 to a box) and shrink wrapped. || Product overwrap label includes: '2/0 (3.0 metric) CP523A Polybond Green Braided, Polyester Coated Nonabsorbable Sterile Suture Rx Only TAPER NSH 36' (90cm) 1/2 26mm Manufactured by CP Medical Portland, OR USA'. || Product box label includes: '2/0 (3.0 metric) CP523A NSH 26 mm 1/2 TAPER POLYBOND Green Polyester Braided Coated Nonabsorbable 36' (90cm) STERILE EO Manufacturer CP Medical Portland, OR USA' . || Product was distributed to single consignee, a distributor in South Africa.
  • Manufacturer
    C P Medical

Manufacturer

C P Medical
  • Adresse du fabricant
    C P Medical, 803 Ne 25th Ave, Portland OR 97232
  • Source
    USFDA