Hudson RCI recalled over labeling errors

Recall date

May 9, 2017

Source

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

Official notice title

Teleflex Medical recalls Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,

Recall number

Z-2251-2017

FDA classification

Class II

Brand / firm

Teleflex Medical

Sold / distributed

CA, CT, FL, IL, IN, MD, MI, MN, MO, MS, NC, NJ, NY, NV, OH, PA, TX, VA, WI and WV.

Why it was recalled

Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.

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

What was recalled

Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,