CLASS II Device recall · Reported 8 Jul 2020 · FDA Enforcement Report
Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit recalled
Westmed is recalling Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infant, 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
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-2434-2020
- 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
- Reason category
- Mold
- Device type
- Other Medical Devices
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;Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0415, 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 CaliforniaGeorgiaIllinoisMassachusettsMichiganMissouriNorth CarolinaOhioOregonTexasVirginiaWisconsin
Questions about this recall
Why was it 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.
Which lots are affected?
101118T42, 101118T44, 102918T01, 080618T02, 080618T03 , 101118T43, 102918T02.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 85576This product is part of a recall event; the main page for the event is Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask recalled | Westmed | Mold | Nationwide | |
| CLASS II | Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask recalled | Westmed | Mold | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS II | REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask recalled | Westmed | Other | Nationwide |
| Device | CLASS II | REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut recalled | Westmed | Other | Nationwide |
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