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
    69373
  • Event Risk Class
    Class 2
  • Event Number
    Z-0140-2015
  • Event Initiated Date
    2014-09-22
  • Event Date Posted
    2014-10-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-02-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130358
  • 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 five lots of monoswift pgcl [poly(glycolide-co-caprolactone)] absorbable surgical suture for failing to meet the minimum tensile strength as dictated by usp was not met over the length of the product's shelf life.
  • Action
    CP Medical Inc.notified their customers between September 23 through October 3, 2014, of the recall via telephone or e-mail and followed up with a certified letter. Customers were advised to discontinue sale and/or use of the recalled product and return all existing stock to CP Medical. CP Medical also requested their customers to notify their downstream customers of the recall and request they return any unused recalled product, as well as provide information to them regarding distribution of the product. Customers are being asked to fill out and return a questionnaire regarding the recalled product and contact CP Medical Customer Service Representative at 1-800-950-2763 for return authorization and shipping account number. All shipping costs including those from downstream customers will be paid for by CP Medical. Replacement product or credit will be provided.

Device

Monoswift
  • Model / Serial
    Product Lot Number (s) Code  L345; 130618-12. L346; 140304-14. L463; 130513-16. L923; 130729-17; 140127-02. L942; 140117-03; 140128-06.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution including the states of: AR, AZ, CA, FL, ME, MI, NE, OR, SC, and WA
  • Product Description
    Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. 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.
  • Manufacturer
    C P Medical, Inc.

Manufacturer

C P Medical, Inc.
  • Manufacturer Address
    C P Medical, Inc., 803 NE 25th Ave, Portland OR 97232-2304
  • Manufacturer Parent Company (2017)
    Juniper Holdings Inc.
  • Source
    USFDA