Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for use on compatible I...

FDA Device Recall #Z-2436-2020 — Class II — January 15, 2019

Recall Summary

Recall Number Z-2436-2020
Classification Class II — Moderate risk
Date Initiated January 15, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Westmed, Inc.
Location Tucson, AZ
Product Type Devices
Quantity 48 cases

Product Description

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.

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.

Lot / Code Information

101518U04, 102318U07, 101618U03.

Other Recalls from Westmed, Inc.

Recall # Classification Product Date
Z-0263-2025 Class II 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF... Sep 27, 2024
Z-0746-2021 Class II REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50... Nov 11, 2020
Z-0745-2021 Class II REF 0562K (Adult Elongated O2/CO2 Mask - Produc... Nov 11, 2020
Z-0743-2021 Class II REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing... Nov 11, 2020
Z-0741-2021 Class II REF 3102-E, Elongated Oxygen Mask, Adult Oxygen... Nov 11, 2020

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.