FDA Device recall Z-2435-2020
Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask
- FDA Device
- Class II
- terminated
- Published 2020-07-08
On 2020-07-08 the FDA classified a Class II recall of Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask 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
| Agency | FDA Device |
|---|---|
| Recall number | Z-2435-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-15 |
| Published | 2020-07-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Westmed |
| Distribution | US |
Product
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.
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_info | 101618U02, 102318U06, 101518U03. |
|---|
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-2435-2020%22
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