Events

Recall of Device Recall MediVac(TM) Flex Advantage(TM) Suction Canister Liner

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardinal Health 200, LLC.

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
    79702
  • Event Risk Class
    Class 2
  • Event Number
    Z-1546-2018
  • Event Initiated Date
    2018-03-28
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163108
  • 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
    Apparatus, suction, operating-room, wall vacuum powered - Product Code GCX
  • Reason
    Products may be missing a one-way valve on the fluid patient port.
  • Action
    Cardinal Health sent an Urgent Product Recall letter dated March 28, 2018, Please take the following actions: 1. INSPECT your inventory for the affected product code and lot number (listed on package) 2. SEGREGATE and QUARANTINE all on-hand product 3. RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652- 9648, whether or not you have affected product, indicating the product code, lot and quantity of product you've quarantined 4. CONTACT Customer Service at 800-964-5227 to arrange for return and credit of any affected product . For further questions, please call (800) 292- 9332.

Device

Device Recall MediVac(TM) Flex Advantage(TM) Suction Canister Liner
  • Model / Serial
    a) REF 6561-910C, Lot Numbers: J802-384, J802-391 b) REF 6561-916K, Lot Number: J802-386 c) REF 6561-920C, Lot Number: J802-396
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the state of MA
  • Product Description
    Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: || a) REF 6561-910C || b) REF 6561-916K || c) REF 6561-920C || To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in operating rooms but are also used outside the surgical field as well as post-operatively within patient suites. The collection containers hold the fluids until they are ready for proper disposal. Sources of vacuum range from wall suction (central vacuum piped throughout the healthcare facility) to liposuction devices (portable suction pumps).
  • Manufacturer
    Cardinal Health 200, LLC

Manufacturer

Cardinal Health 200, LLC
  • Manufacturer Address
    Cardinal Health 200, LLC, 3651 Birchwood Dr, Waukegan IL 60085-8337
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA