Events

Recall of Device Recall Halyard

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Halyard Health, 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
    79531
  • Event Risk Class
    Class 2
  • Event Number
    Z-1427-2018
  • Event Initiated Date
    2018-02-07
  • 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=162598
  • 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
    Catheters, suction, tracheobronchial - Product Code BSY
  • Reason
    Certain flex connectors supplied with halyard closed suction kits with flex connector may become loose or disconnect before use or during use.
  • Action
    Customers were notified via mail and/or email on about 02/07/2018. Instructions for distributors included to notify all affected customers who may have received potentially impacted products and to complete and return the Distributor Acknowledgement Form. Instructions for customers included to ensure adequate connection of the Flex Connector to Swivel Connector before use of the product by following. This accomplished by ensuring a tight fit is achieved on the Swivel with the Flex Connector advanced approximately three-quarters over the Swivel, so a gap remains visible. If and adequate connection is observed, the Flex Connector may be replaced with a new, sterile Flex Connector and the system connection should be re-evaluated. Lastly, if use of a Flex Connector with the ventilator circuit is optional, the closed suction Swivel Connector can be connected directly to the ventilator circuit. During use, if a disconnection between the Flex Connector and Swivel Connector is observed during use, replace the Flex Connector with a new, sterile Flex Connector (e.g. HYH Product # 1115) and ensure adequate connection as described in this notice. If an inadequate connection occurs, Halyard Health instructs customers to safe the Flex Connector and report it via the Product Complaint Process (PIQ) and the local Halyard Health Sales Representative will assist. Additionally customers were instructed to complete and return the Acknowledgement Form and distribute the recall notice to all clinicians in the facility that may be impacted.

Device

Device Recall Halyard
  • Model / Serial
    Product Description, (Product code):    a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE), (2160);  b. HALYARD* 12 FR TRACH CARE DSE ENDO, (2160-5);  c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE), (21603);  d. HALYARD* 12FR TRACH CARE DSE TRACH, (21603-5);  e. HALYARD* 14FR DSE 21.3IN/54CM (GREEN), (22108130, 2210, 22106, 22107, 22108, 22108147, 8224);  f. HALYARD* 14FR TRACH CARE DSE ENDO, (2210-5);  g. HALYARD* 14FR DSE 12IN/30.5CM (GREEN), (22103, 221037, 221038, 8223, 221036);  h. HALYARD* 14FR TRACH CARE DSE TRACH, (22103-5);  i. HALYARD* 14FR DSE 12IN/30.5CM, (221036-5);  j. HALYARD* 14FR TRACH CARE WET PAK* DSE MDI TRACH, (2210386-5);  k. HALYARD* 14FR TRACH CARE WET PAK* DSE ENDO, (22106-5);  l. HALYARD* 14FR TRACH CARE WET PAK* DSE DIR TIP ENDO, (221069-5);  m. HALYARD* 14 FR TRACH CARE DSE DUAL LUMEN ENDO, (22107-5);  n. HALYARD* 14FR TRACH CARE DSE MDI ENDO, (22108-5);  o. HALYARD* 14FR DSE 22.2IN/56 CM (GREEN), (22108148, 22109);  p. HALYARD* 14FR TRACH CARE DSE DIR TIP ENDO, (22109-5);  q. HALYARD* 16FR DSE 21.3IN/54CM (ORANGE), (2260, 22606);  r. HALYARD* 16FR TRACH CARE DSE ENDO, (2260-5);  s. HALYARD* 16FR TRACH CARE WET PAK* DSE ENDO, (22606-5)
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution. US nationwide including Puerto Rico, ARGENTINA, AUSTRALIA, BAHAMAS, BELGIUM, BOLIVIA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REP., ECUADOR, EL SALVADOR, GUATEMALA, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, LEBANON, MALAYSIA, MEXICO, NEW ZEALAND, PERU, PHILIPPINES, QATAR, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, THAILAND, UNITED KINGDOM, and UNITED ARAB EMIRATES.
  • Product Description
    Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following: || a. HALYARD* 12FR DSE 21.3IN/54CM (WHITE); || b. HALYARD* 12 FR TRACH CARE DSE ENDO; || c. HALYARD* 12FR DSE 12IN/30.5CM (WHITE); || d. HALYARD* 12FR TRACH CARE DSE TRACH; || e. HALYARD* 14FR DSE 21.3IN/54CM (GREEN); || f. HALYARD* 14FR TRACH CARE DSE ENDO; || g. HALYARD* 14FR DSE 12IN/30.5CM (GREEN); || h. HALYARD* 14FR TRACH CARE DSE TRACH; || i. HALYARD* 14FR DSE 12IN/30.5CM; || j. HALYARD* 14FR TRACH CARE WET PAK* DSE MDI TRACH; || k. HALYARD* 14FR TRACH CARE WET PAK* DSE ENDO; || l. HALYARD* 14FR TRACH CARE WET PAK* DSE DIR TIP ENDO; || m. HALYARD* 14 FR TRACH CARE DSE DUAL LUMEN ENDO; || n. HALYARD* 14FR TRACH CARE DSE MDI ENDO; || o. HALYARD* 14FR DSE 22.2IN/56 CM (GREEN); || p. HALYARD* 14FR TRACH CARE DSE DIR TIP ENDO; || q. HALYARD* 16FR DSE 21.3IN/54CM (ORANGE); || r. HALYARD* 16FR TRACH CARE DSE ENDO; || s. HALYARD* 16FR TRACH CARE WET PAK* DSE ENDO
  • Manufacturer
    Halyard Health, Inc

Manufacturer

Halyard Health, Inc
  • Manufacturer Address
    Halyard Health, Inc, 5405 Windward Pkwy, Alpharetta GA 30004-3894
  • Source
    USFDA