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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a functional incompatibility (non-compliant connections) rather than a direct safety hazard like injury or illness. This aligns with the rubric for moderate severity involving functional defects or low-risk issues where no harm is reported.
Plain-English summary
Westmed, Inc. is recalling 48 cases of Neo-Vent Infant T-Piece Resuscitation Circuits with Neonatal Masks (REF 0421). The affected units are intended for use on compatible Infant Resuscitators and were distributed worldwide, including nationwide in the United States and in Spain.
The recall was initiated because a repair to an adapter mold resulted in the production of parts with compliant 10mm ID connections but non-compliant 15mm OD connections. This manufacturing defect prevents facilities with infant resuscitators that connect via the 15mm OD fitting from using these circuits.
Affected lot codes include 101518U04, 102318U07, and 101618U03. Healthcare facilities and consumers should stop using these specific circuits and contact Westmed, Inc. for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Westmed, Inc.
- Affected units
- 48
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 101518U04
- 102318U07
- 101618U03.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Westmed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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