Events

Recall of Perfusion Tubing Set

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sorin Group USA, 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
    57052
  • Event Risk Class
    Class 2
  • Event Number
    Z-0381-2011
  • Event Initiated Date
    2010-10-07
  • Event Date Posted
    2010-11-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95268
  • 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
    Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Reason
    Defective product packaging may compromise product sterility.
  • Action
    Sorin Group sent an "URGENT: FIELD SAFETY NOTICE" letter dated October 7, 2010, to all customers. The letter described the product, problem and action to be taken by customer. The customers were instructed to check all affected inventory to exam for holes. Any damaged products were to be returned to Sorin. If no damage was found, product could be used. The customers were also instructed to contact Sorin Cardiopulmonary Customer Service at 1-800-650-2623 to return product and receive replacement; they were to share this information with all personnel who may use this product; and to complete and return the attached Customer Response Form via the self-addressed prepaid envelope provided or fax to (303) 467-6502 as soon as possible. For further information, contact 1-800-650-2623.

Device

Perfusion Tubing Set
  • Model / Serial
    Lot No. 1009600060, 1010200049, 1012500030, 1014500022, 1020200040, 1022300027
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: CA, FL, IL, IN, KS, MD, MO, NE, NJ, NM, TN, TX, and VA.
  • Product Description
    Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500900, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 || Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
  • Manufacturer
    Sorin Group USA, Inc.

Manufacturer

Sorin Group USA, Inc.
  • Manufacturer Address
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Source
    USFDA