CLASS II Device recall · Reported 8 Jul 2020 · FDA Enforcement Report

Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask recalled

Westmed is recalling Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask, distributed nationwide in the US. The recall was initiated on 15 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes101618U02, 102318U06, 101518U03.

Quantity recalled35 cases

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2435-2020
FDA event ID: 85576
Recalling firm: Westmed, Tucson, AZ
Classification: Class II
Status: Terminated
Recall initiated: 15 Jan 2019
FDA classified: 26 Jun 2020
Reported: 8 Jul 2020
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Mold
Device type: Masks, Gloves & PPE

Timeline

15 Jan 2019	Recall initiated by company
26 Jun 2020	Classified by FDA	+528 days
8 Jul 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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 as listed by the FDA

Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0420, Qty:10, Length: 60" (1.5cm), Rx Only.

Where it was 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.

Nationwide California Georgia Illinois Massachusetts Michigan Missouri North Carolina Ohio Oregon Texas Virginia Wisconsin

Questions about this recall

Is Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask recalled?

Yes. Westmed recalled Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask on 15 Jan 2019. The recall is Class II and its status is Terminated. Recall number Z-2435-2020.

Why was it recalled?

Which lots are affected?

101618U02, 102318U06, 101518U03.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Westmed

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6 Nov 2024Device	CLASS II	Flex Extenders, 2" OD ID recalled by Westmed	Westmed	Foreign Material	30 states
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