Class II — Westmed, Inc.
| Recalling firm | WESTMED, INC. |
|---|---|
| Registered facility | WESTMED, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 35 cases |
| Distribution | 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. |
| Initiated | 2019-01-15 |
| Classified | 2020-06-26 |
| Terminated | 2021-02-05 |
| Recall number | Z-2435-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Westmed, Inc. (Z-2435-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85576/
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