The Recall Desk

FDA (Devices) recall action 85576

Westmed, Inc. recalled 3 products on 2020-07-08

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2020-07-08
Critical
0
Units
708

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··2020-07-08

    Westmed Recalls Neo-Vent Infant T-Piece Resuscitation Circuits Due to Fit Issues

    Westmed, Inc. is recalling Neo-Vent Infant T-Piece Resuscitation Circuits because a mold repair resulted in non-compliant 15mm OD connections that prevent use with compatible infant resuscitators.

    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.
    Category
    Distribution
    13 states
  • ModerateFDA (Devices)··2020-07-08

    Westmed Recalls Neo-Vent Infant T-Piece Resuscitation Circuits Due to Fit Issues

    Westmed, Inc. is recalling Neo-Vent Infant T-Piece Resuscitation Circuits because a manufacturing error resulted in non-compliant 15mm OD connections, preventing use with compatible infant resuscitators.

    Product
    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.
    Category
    Distribution
    13 states
  • ModerateFDA (Devices)··2020-07-08

    Westmed Neo-Vent Infant T-Piece Resuscitation Circuit Recall for Non-Compliant Connections

    Westmed is recalling Neo-Vent Infant T-Piece Resuscitation Circuits because a mold repair resulted in non-compliant 15mm OD connections, preventing use with compatible infant resuscitators.

    Product
    Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible Infant Resuscitators. 15mm OD x 10mm ID connector; REF 0421, Qty:10, Length: 60" (1.5cm), Rx Only.
    Category
    Distribution
    13 states