Reported Jul 8, 2020 · Terminated
Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use on compatible Infant Resuscitators.…
Westmed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Westmed, Inc. · 5580 S Nogales Hwy Ste 170 · Tucson, AZ · 85706-3333
Is this the product you have?
- 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
- Qty10
- Length60" (1.5cm), Rx Only
- Lot codes and dates
101618U02102318U06101518U03
- Amount recalled
- 35 cases
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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