RecallRadar

FDA Device recall Z-2434-2020

Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector

On 2020-07-08 the FDA classified a Class II recall of Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector by Westmed, citing 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 i….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2434-2020
ClassificationClass II
Statusterminated
Initiated2019-01-15
Published2020-07-08
Last updated2026-09-13 11:55 UTC
CompanyWestmed
DistributionUS

Product

Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, Qty:10, Length: 60" (1.5cm), Rx Only.

Reason

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.

Identifiers

code_info101118T42, 101118T44, 102918T01, 080618T02, 080618T03 , 101118T43, 102918T02.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2434-2020%22

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