Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2434-2020 — 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.

U.S. FDA — Device Enforcement · United States · 2019-01-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2434-2020
Date of alert: 2019-01-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Westmed, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-2434-2020 — 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.

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