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 mold repair resulted in non-compliant 15mm OD connections that prevent use with compatible infant resuscitators.
What this means for you
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. The hazard is a functional defect (incompatibility) rather than a direct safety risk like contamination or injury, fitting the 'Moderate' criteria for minor issues or voluntary precautionary actions without reported harm.
Plain-English summary
Westmed, Inc. is recalling 35 cases of Neo-Vent Infant T-Piece Resuscitation Circuits with Infant Mask (REF 0420). The affected lots are identified by codes 101618U02, 102318U06, and 101518U03. These circuits are intended for use on compatible infant resuscitators and are prescription-only.
The recall was initiated because a repair to an adapter mold resulted in parts being produced with compliant 10mm ID connections but non-compliant 15mm OD connections. This defect prevents facilities using infant resuscitators that connect via the 15mm OD fitting from using these circuits.
The affected products were distributed worldwide, including nationwide in the United States (specifically in CA, GA, IL, OH, MA, MI, MO, NC, OR, TX, VA, and WI) and in Spain. Healthcare facilities should stop using the affected circuits and contact Westmed, Inc. for instructions on return or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Westmed, Inc.
- Affected units
- 35
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)
- 101618U02
- 102318U06
- 101518U03.
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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