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U.S. Department of Health and Human Services

Class 1 Device Recall Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set

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 Class 1 Device Recall Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve setsee related information
Date Initiated by FirmJune 26, 2025
Date PostedJuly 30, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2167-2025
Recall Event ID 97222
Product Classification Set, tubing and support, ventilator (w harness) - Product Code BZO
ProductBreathing 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.
Code Information UDI-DI: 07630002802963, Lots: 199675, 199676
FEI Number 3014766741
Recalling Firm/
Manufacturer		 Hamilton Medical AG
Parc Industrial Vial 10
Domat/Ems Switzerland
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionStarting on 6/26/2025, recall notices were emailed to customers who were asked to do the following: Return affected devices. If one of the affected breathing circuits would be already in use with a patient, it is requested to exchange it and discard the product after replacement. If you are a distributor, please forward to any organization where potentially affected product has been transferred. Complete and return the acknowledgement form via email to complaints@hamiltonmedical.com If you have any questions contact firm at: complaints@hamiltonmedical.com and 800-426-6331
Quantity in Commerce2,560
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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