Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask recalled over mold contamination

Recall date

January 15, 2019

Source

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

Official notice title

Westmed, Inc. recalls Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 1…

Recall number

Z-2436-2020

FDA classification

Class II

Brand / firm

Westmed, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of CA, GA, IL,OH, MA, MI, MO, NC, OH, OR, TX, VA, and WI. The country of Spain.

Why it was recalled

A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and non-compliant 15mm OD connections. This resulted in facilities with infant resuscitators that connect via the 15mm OD fitting not being able to use those circuits.

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

What was recalled

Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only.