Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask — Class II medical device recall Z-2436-2020
Terminated recall by Westmed, Inc., reported 2020-07-08, distributed nationwide. A repair was made to an adapter mold resulting in parts being produced with compliant 10mm ID connections and
| Recall number | Z-2436-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Westmed, Inc., Tucson, AZ, United States |
| Recall initiated | 2019-01-15 |
| Classified | 2020-06-26 |
| Reported by FDA | 2020-07-08 |
| Terminated | 2021-02-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | ES |
| Quantity | 48 cases |
| Reason classes | microbial contamination |
| Pathogens | mold |
| Model numbers | 0421 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2436-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.