medical Class II Updated 2018-04-25

Halyard Health, Inc recalls Halyard Closed Suction System for Adults, Double Swivel Elbo

Recalled Product

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

Hazard / Issue

Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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)

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