Gibeck Humid-Vent 2S Flex DC recalled over sterility concerns

Recall date

April 11, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

TELEFLEX MEDICAL INC recalls (1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-steril…

Recall number

Z-1126-2022

FDA classification

Class II

Brand / firm

TELEFLEX MEDICAL INC

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The countries of Austria, Australia, Belgium, Canada, Chile, Czech Republic, Finland,…

Why it was recalled

Reports received of torn corrugated breathing tubes.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

(1) Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile; (2) Gibeck Humid-Vent 2S Flex DC, Product #17732, non-sterile; (3) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19061, sterile; (4) Gibeck Humid-Vent Filter Compact S with Smooth-Flo/Swivel, Product #19062, non-sterile; and (5) Gibeck Humid-Vent Filter Compact S with Flex Tube, Product #19812, non-sterile.