Home / Recalls / Westmed, Inc. / Z-2435-2020

Z-2435-2020 Class II Terminated

Recalled by Westmed, Inc. — Tucson, AZ

Recall Details

Product Type
Devices
Report Date
July 8, 2020
Initiation Date
January 15, 2019
Termination Date
February 5, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
35 cases

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.

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.

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.

Code Information

101618U02, 102318U06, 101518U03.

Other recalls by Westmed, Inc.

  • Z-0263-2025 Class II — 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" (September 27, 2024)
  • Z-0745-2021 Class II — REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with (November 11, 2020)
  • Z-0746-2021 Class II — REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail (November 11, 2020)
  • Z-0742-2021 Class II — Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Onl (November 11, 2020)
  • Z-0744-2021 Class II — REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female (November 11, 2020)
  • Z-0743-2021 Class II — REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' (November 11, 2020)
  • Z-0741-2021 Class II — REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, R (November 11, 2020)
  • Z-2434-2020 Class II — Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infa (January 15, 2019)
  • Z-2436-2020 Class II — Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for us (January 15, 2019)
  • Z-0106-2013 Class II — Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1 (January 18, 2011)