Events

Recall of Monoswift

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
    68153
  • Event Risk Class
    Class 2
  • Event Number
    Z-1708-2014
  • Event Initiated Date
    2014-04-23
  • Event Date Posted
    2014-06-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-09-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127056
  • 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
    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
  • Model / Serial
    Lot 130826-08, expiration 2015-07.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    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.
  • Manufacturer Address
    C P Medical Inc., 803 NE 25th Avenue, Portland OR 97232-2304
  • Source
    USFDA