Vyaire Flexible Patient Circuit 3100A Distributed Without U.S. Approval
Vyaire Medical recalled 188 Flexible Patient Circuit 3100A units distributed in Florida that were approved only for use outside the United States. The circuits were mistakenly distributed in the U.S. market.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is regulatory non-compliance—circuits approved only for use outside the United States were distributed in the U.S. market. This is primarily a distribution compliance issue rather than a direct product defect.
Plain-English summary
Vyaire Medical is recalling 188 Flexible Patient Circuit 3100A units (REF 29028-003) intended for use with the 3100A High Frequency Oscillatory Ventilator (HFOV). The recall affects circuits with the following lot numbers: 4060467, 4165459, 4167324, 4180598, 4180599, 4180604, 4180609, 4180610, 4180611, 4182155, 4182156, 4182157, 4182158, 4182159, 4182160, 4182161, 4182162, 4182163, 4182164, 4183410, 4183411, 4188658, 4190144, 4253788, 4253789, and 4180603 (UDI/DI 10190752159747).
These patient circuits were approved for use only outside the United States but were distributed in the U.S. market, specifically in Florida.
Healthcare facilities in Florida that received these units should verify whether they have these circuits in inventory and take appropriate corrective action in accordance with FDA guidance and their facility protocols.
Vyaire Medical and the FDA are working to address this distribution error. Affected facilities should contact the manufacturer for instructions on proper handling of recalled units.
The recalled product
- Product
- vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)
- Manufacturer
- Vyaire Medical
- Hazard
- regulatory-non-compliance
- unapproved-distribution
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 (20)
- UDI/DI 10190752159747: Lot/serial numbers: 4060467
- 4165459
- 4167324
- 4180598
- 4180599
- 4180604
- 4180609
- 4180610
- 4180611
- 4182155
- 4182156
- 4182157
- 4182158
- 4182159
- 4182160
- 4182161
- 4182162
- 4182163
- 4182164
- 4183410
Distribution
Distribution scope not specified by the agency.
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