Events

Recall of Device Recall Monomid NonAbsorbable 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
    59759
  • Event Risk Class
    Class 2
  • Event Number
    Z-3177-2011
  • Event Initiated Date
    2011-06-29
  • Event Date Posted
    2011-09-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103603
  • 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, nonabsorbable, synthetic, polyamide - Product Code GAR
  • Reason
    Unapproved dye was used in manufacturing the non-absorbable blue nylon suture material.
  • Action
    CP Medical sent a "RECALL NOTICE" letter dated June 29, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected products in the human market and to return all their existing stock. A Recall Checklist was enclosed for customers to complete and return. Contact Customer Service at 1-800-950-2763 for a Return Good Authorization and shipping account number. The firm will pay for shipping cost and replace product at no cost to customers.

Device

Device Recall Monomid NonAbsorbable Suture
  • Model / Serial
    LOT Numbers: 070205-04, 070205-05, 070221-05, 070322-04, 070410-02, 070430-08, 070517-12, 070702-03, 070726-06, 070824-04, 070924-08, 071024-05, 080103-24, 080111-02, 080211-01, 080227-09, 080424-21, 080424-22, 080424-24, 080602-18, 080825-11, 080911-05, 081002-12, 081202-02, 090211-07, 090310-14, 090415-03, 090429-07, 090515-04, 090706-10, 090803-06, 090904-02, 091110-15, 091119-07, 100114-39, 100122-05, 100305-05, 100317-11, 100505-18, 100702-05, 100706-01, 100810-08, 100921-10, 101129-19, 101208-01, B0605230, D0510140, D0610330, D0611040, G0220310, G0619440, G0619530-1, H0523640, H0622330, J0528740, J0627630-1, J0628240, L0534830, and L0635430-1.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Italy, Romania, South Africa, and Taiwan.
  • Product Description
    Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with different sizes and different needle sizes. || The products are labeled in parts. || These sutures are intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological surgery.
  • 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