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Westmed, Inc. recalls Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15
Recalled July 8, 2020 · FDA recall Z-2436-2020 · Westmed
Hazard
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. · FDA Class II
Units
48 cases
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
Westmed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →