Events

Recall of Device Recall Malleable Pericardial Sump

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
    46745
  • Event Risk Class
    Class 2
  • Event Number
    Z-1177-2008
  • Event Initiated Date
    2008-01-24
  • Event Date Posted
    2008-06-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68207
  • 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
    suction pump - Product Code DTS
  • Reason
    Fragment of material: the product may have a loose, stainless steel stringer flash located at the distal tip of the product.
  • Action
    CalMed emailed letters to consignees on 1/24/2008 notifying customers of the recall. The letter advises that that the following Medical Devices are subject to an immediate Voluntary Recall for Correction: Pericardial Sump (Catalog #SU-20601), Pericardial Sump (Catalog #SU-20602), and Malleable Pericardial Sump (Catalog #SU-20802). It is asked that further distribution or use of any remaining product should cease immediately. Where appropriate, the firm asks that consignees notify their own customers who received the product of the same. The Product is being recalled due to a potentially loose, stainless steel stringer flash located at the distal tip of the Product. Customers are asked to contact the firm's Quality Assurance Manager immediately for purposes of issuing a Returned Goods Authorization and coordinating the return of the Subject Medical Devices such that they may be inspected and nonconforming product removed. A response is requested via e-mail.

Device

Device Recall Malleable Pericardial Sump
  • Model / Serial
    Catalog Number SU-20802, Lot Numbers: S040870 S041515 S050537 S050907 S050919 S051982 S052118 S052325 S060056 S060158 S060909 S060924 S070307 S071047 S071462NS S071463 S071620 S071754 and S071985.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, Turkey, Brazil, Germany, Italy, Spain, Philippines, South Africa, Japan, Israel, Saudi Arabia, United Arab Emirates, India, Ireland, China, Hungary, Poland, Taiwan, Belgium, Pakistan, Lithuania, Greece, Canada, Syria, Israel, Austria, Denmark, Bangladesh, Costa Rica, Mexico, Spain, and Sultanate of Oman.
  • Product Description
    CalMed Malleable Pericardial Sump, Single Use Only. Do Not Reuse. REF SU-20802; CalMed Laboratories, Costa Mesa, CA 92626
  • 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