Hamilton coaxial breathing circuits may have a crack in blue tubing
Coaxial breathing circuit sets for HAMILTON-C1, T1 and MR1 ventilators are being recalled because the blue tubing that delivers fresh gas may be cracked, which can cause rebreathing of exhaled gases. 2,560 units affected.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.
Plain-English summary
The 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, UDI-DI 07630002802963, is being recalled. The action covers 2,560 units from lots 199675 and 199676.
According to the manufacturer, the ventilator coaxial breathing circuit may have a crack in the blue tubing, which is used to deliver fresh gas to the patient. The notice states the crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis and, if unrecognised, organ damage. The FDA classified the action as Class I, its most serious classification.
Distribution was nationwide in the United States, in New Hampshire, New York, Connecticut, Pennsylvania, Illinois, Maine, Colorado, North Carolina and New Jersey among other states.
Facilities should identify affected stock using the REF, UDI-DI and lot numbers above, quarantine it, and follow the instructions issued by the manufacturer.
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
- Affected units
- 2,560
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
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