Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF: 260128, used with HAMILTON-C1, H
Summary
The FDA issued a Class I for Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve se by Hamilton Medical AG. Reason: Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise ins.
Details
Source
Device Recall
External ID
Z-2167-2025
Action Date
2025-08-06
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: UDI-DI: 07630002802963, Lots: 199675, 199676
Quantity Affected: 2,560
Reason for Recall
Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. 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 unrecognized organ dysfunction.
Distribution
US Nationwide distribution in the states of NH, NY, CT, PA, IL, ME, CO, NC, NJ, UT, TX, GA, SC, VA, IN, SD, MO, OR, TN, MA, AZ, NM.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-26
Company
Domat/Ems
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 157 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Hamilton Medical AG has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hamilton Medical AG) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hamilton Medical AG have FDA actions?
Hamilton Medical AG has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2167-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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