Alpharetta, GA, United States
Halyard Health, Inc recalls
2 recalls recorded since 2018, most recently on 7 February 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 7 February 2018
- Terminated
- 18 January 2022
- Reason
- Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.
- 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, JA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1428-2018, Z-1429-2018, Z-1427-2018
- Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* TURBO-CLEANIN
- Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALY
- 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. HA
Terminated Class II Medical devices
- Recall started
- 13 December 2017
- Terminated
- 4 November 2021
- Reason
- The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with ANTI-IV* connector (Product Code 20-9551Trak2A) may be visible within the window of the exit port of the feeding tube. Based on specifications, the transmitting stylet in the NG tube should not be visible within the port window.
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AR, CA, CO, GA, IA, LA, MI, MN, NM, TX; and country of Germany. Distributed internationally to Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1277-2018
- CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm The device is used in patients that require inte
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.