Events

Recall of Device Recall MonoDox Synthetic Absorbable Suture

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by C P Medical Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    60173
  • Event Risk Class
    Class 2
  • Event Number
    Z-0259-2012
  • Event Initiated Date
    2009-01-02
  • Event Date Posted
    2011-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104675
  • Notes / Alerts
    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.
  • Extra notes in the data
    Suture, surgical, absorbable, polydioxanone - Product Code NEW
  • Reason
    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 MonoDox Synthetic Absorbable Suture
  • Model / Serial
    M397, M398 (Butler code 029254)
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    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 4/0 (1.5 Metric), NFS-2 Needle (Product code M397-Polydioxanone) or size 3/0 (2.0 Metric) (Product code M398 {Butler code 029254}). || Product is labeled in part: "***POLYDIOANONE Violet (PDO) Monofilament Absorbable Suture***". || 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.
  • Manufacturer Address
    C P Medical Inc., 803 NE 25th Avenue, Portland OR 97232-2304
  • Source
    USFDA