Westmed, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2435-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 15, 2019

Date Posted: July 8, 2020

Recall Number: Z-2435-2020

Event ID: 85576

Reason for Recall:

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.

Status: Terminated

Product Quantity: 35 cases

Code Information:

101618U02, 102318U06, 101518U03.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated