Breathing circuit sets may crack, compromising gas delivery in Hamilton ventilators
Breathing circuit sets for Hamilton ventilators may have cracks that prevent adequate fresh gas delivery, causing dangerous rebreathing of exhaled gases and potential organ dysfunction.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a critical medical device component. The hazard—cracking in tubing that delivers fresh gas to ventilator patients—can cause dangerous rebreathing of exhaled gases leading to hypercapnia, respiratory acidosis, and organ dysfunction. The FDA's Class I classification and the serious nature of the defect in a life-support device justify a Severe rating.
Plain-English summary
Hamilton Medical AG is recalling certain breathing circuit sets (reference number 260128) used with HAMILTON-C1, HAMILTON-T1, and HAMILTON-MR1 ventilators. The sets may have cracks in the blue tubing that is designed to deliver fresh gas to patients.
The cracks can compromise inspiratory and expiratory flows, potentially leading to partial or complete rebreathing of exhaled gases. This could result in acute hypercapnia (elevated carbon dioxide levels), respiratory acidosis (dangerous changes in blood pH), and organ dysfunction if the defect is not recognized.
Approximately 2,560 units have been distributed nationwide across 22 states, including New Hampshire, New York, Connecticut, Pennsylvania, Illinois, Maine, Colorado, North Carolina, New Jersey, Utah, Texas, Georgia, South Carolina, Virginia, Indiana, South Dakota, Missouri, Oregon, Tennessee, Massachusetts, Arizona, and New Mexico. The affected lots are 199675 and 199676.
The recalled product
- Product
- Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators.
- Manufacturer
- Hamilton Medical AG
- Hazard
- breathing-circuit-crack
- gas-delivery-failure
- hypercapnia
- respiratory-acidosis
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)
- UDI-DI: 07630002802963
- Lots: 199675
- 199676
Distribution
Distributed nationwide across the United States.
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