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

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. — recall Z-2435-2020

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-2435-2020
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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