Events

Recall of Device Recall CalMed SU12202NS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by California Medical Laboratories 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
    63896
  • Event Risk Class
    Class 2
  • Event Number
    Z-0650-2013
  • Event Initiated Date
    2012-11-02
  • Event Date Posted
    2013-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114968
  • 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
    Sucker, cardiotomy return, cardiopulmonary bypass - Product Code DTS
  • Reason
    California medical laboratories, inc. has identified an issue with the rigid tip suction wand. due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
  • Action
    CalMed sent an Urgent Field Safety Notice dated November 2, 2012, to all affected customers by certified mail and additionally followed up via electronic mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact Sorin Group USA's Customers Service Department at +1-800-650-2623 to return any unused product and order replacements. Customers were also asked to communicate the important safety information to all potential users within their organization or any other organization where the affected product may have been transferred and to maintain awareness of this communication for an appropriate period of time to ensure effectiveness of the corrective action. Customers were asked to return all unused product to CalMed Labs. Customers with questions were instructed to contact California Medical Laboratories at +1-714-556-7365. For questions regarding this recall call 714-556-7365.

Device

Device Recall CalMed SU12202NS
  • Model / Serial
    Catalog No: SU-12202NS Lot No: S112468N, S120196N, S120197N
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AZ, FL, CA, LA, CO, and MS. Internationally to Canada, Israel, Greece, Hong Kong, India, Ireland, Jordan, Lebanon, Malaysia, Netherlands, Russia, Saudi Arabia, South Africa and Spain.
  • Product Description
    Rigid Tip Suction Wand || Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. || The Suction Wands are indicated for use to remove excess fluid from the surgical field.
  • Manufacturer
    California Medical Laboratories Inc

Manufacturer

California Medical Laboratories Inc
  • Manufacturer Address
    California Medical Laboratories Inc, 1570 Sunland Ln, Costa Mesa CA 92626-1515
  • Source
    USFDA