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.
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 fit issue rather than a direct safety hazard or reported injury, aligning with the criteria for moderate severity involving low-risk issues or voluntary precautionary actions.
Plain-English summary
Westmed, Inc. is recalling 625 cases of Neo-Vent Infant T-Piece Resuscitation Circuits (REF 0415). These circuits are intended for use with compatible infant resuscitators and are distributed worldwide, including in the United States and 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 the affected circuits.
The affected units are identified by the following codes: 101118T42, 101118T44, 102918T01, 080618T02, 080618T03, 101118T43, and 102918T02. Facilities should stop using the affected circuits and contact Westmed, Inc. for instructions on how to proceed.
The recalled product
- 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.
- Manufacturer
- Westmed, Inc.
- Hazard
- Affected units
- 625
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 (7)
- 101118T42
- 101118T44
- 102918T01
- 080618T02
- 080618T03
- 101118T43
- 102918T02.
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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