Events

Rappel de Device Recall Halyard

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Halyard Health, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    79531
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1427-2018
  • Date de mise en oeuvre de l'événement
    2018-02-07
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162598
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Catheters, suction, tracheobronchial - Product Code BSY
  • Cause
    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
  • Modèle / numéro de série
    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)
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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
  • Adresse du fabricant
    Halyard Health, Inc, 5405 Windward Pkwy, Alpharetta GA 30004-3894
  • Source
    USFDA