Medline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
Medline is recalling neonatal and infant heated wire breathing circuits due to a risk of sporadic failure and thermal damage at the humidifier connector.
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 risk of significant injury, including airway obstruction and worsening respiratory distress in neonates and infants.
Plain-English summary
Medline Industries, LP is recalling specific neonatal and infant heated wire breathing circuits. The recall involves 271,406 units distributed nationwide in the United States and in Panama. The affected products include various Medline Hudson RCI circuit kits, such as single-limb and dual-limb configurations, as well as Iso-Shield circuits for infants.
The recall is issued because the heated wire connector (pigtail) at the humidifier may experience sporadic failure. This failure can result in discoloration, melting, smoke, a burning odor, or other signs of localized thermal damage. If the device fails, it may predispose infants to bronchospasm, inspissated secretions, airway obstruction, inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway. These issues can lead to elevated oxygen consumption and worsening respiratory distress.
Healthcare facilities and consumers should stop using the affected breathing circuits immediately. Users should check their inventory for the specific Medline Product Numbers/SKUs and Teleflex Product Numbers/SKUs listed in the recall notice. Medline is the recalling firm responsible for managing the recall.
The recalled product
- Product
- Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline Product Number/SKU HUD78001KIT (Teleflex Product Number/SKU 780-01KIT); 2) MEDLINE HUDSON RCI, CIRCUIT, NEO, DUAL LIMB HTD, COLUMN, Medline Product Number/SKU…
- Manufacturer
- Medline Industries, LP
- Affected units
- 271,406
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 (12)
- UDI/DI 10197344010752 (each) 20197344010759 (case)
- All lot numbers
- UDI/DI 10197344010738 (each) 20197344010735 (case)
- UDI/DI 10197344010721 (each) 20197344010728 (case)
- UDI/DI 10197344010714 (each) 20197344010711 (case)
- UDI/DI 10197344010677 (each) 20197344010674 (case)
- UDI/DI 10197344010905 (each) 20197344010902 (case)
- UDI/DI 10197344010929 (each) 20197344010926 (case)
- UDI/DI 10197344010493 (each) 20197344010490 (case)
- UDI/DI 10197344010486 (each) 20197344010483 (case)
- UDI/DI 10197344010479 (each) 20197344010476 (case)
- UDI/DI 10197344010462 (each) 20197344010469 (case)
Distribution
Distributed nationwide across the United States.
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