Medline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Failure
Medline is recalling 20 units of neonatal heated wire breathing circuits due to potential thermal damage that could cause airway obstruction or respiratory distress in infants.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that can cause significant injury, including airway obstruction and respiratory distress in neonates and infants.
Plain-English summary
Medline Industries, LP is recalling 20 units of Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO breathing circuits (Medline Product Number/SKU HUD78019; Teleflex Product Number/SKU 780-19). The affected units were distributed worldwide, including the United States and Panama. The recall covers all lot codes.
The recall is being issued because the heated wire connector (pigtail) at the humidifier may experience sporadic failure, exhibiting discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. This device failure may predispose infants to bronchospasm, inspissated secretions, airway obstruction, inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.
Healthcare facilities and consumers should stop using these specific breathing circuits immediately and contact Medline Industries, LP for instructions on return or replacement.
The recalled product
- Product
- Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit. Respiratory gas humidifier.
- Manufacturer
- Medline Industries, LP
- Affected units
- 20
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 (1)
- All lot codes
Distribution
Distributed nationwide across the United States.
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