Recall Z-1429-2018— Halyard Health, Inc

Class II FDA medical device recall by Halyard Health, Inc, initiated 2018-02-07, terminated 2022-01-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;. Reason: Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use..

Recalling firm

Halyard Health, Inc

Classification

Class II

Status

Terminated

Initiated

2018-02-07

Terminated

2022-01-18

Firm location

Alpharetta, GA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.