FDAFDA · Food and drugs·Recall number Z-2435-2020
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.
Published July 8, 2020 · Recall initiated: January 15, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Westmed, Inc.
- Distributor
- 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.
- Lot
- 101618U02, 102318U06, 101518U03.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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