Z-1963-2015Class II

Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an...

Name: Z-1963-2015 Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an...
Creator: Hamilton Medical, Inc.
Published: 2015-06-01
License: https://open.fda.gov/license/

Hamilton Medical AG / initiated 2015-06-01 / Terminated / root cause: design

FDA source

Hamilton Medical, Inc. began a recall of Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventilators... on 2015-06-01. FDA classified it as Class II and gives the reason as "An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1963-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-01
Posted: 2015-07-02
Terminated: 2015-08-12
Recalling firm: Hamilton Medical AG
Product: Hamilton Medical Infant Flow Sensor, single use, (1.6m), Part number 260177. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
Product code: BZO Set, Tubing And Support, Ventilator (W Harness)
Reason for recall: An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement and decrease the amount of ventilation delivered.
Root cause tag: design
FDA root cause: Device Design
Action: Hamilton Medical Inc sent a Medical Device Safety Notices letter dated May 8, 2015 by traceable method to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact Technical Support Manager at 800-426-6331, Ext 215.
Quantity in commerce: 154 total - all part numbers
Distribution: US Nationwide Distribution.
Product codes and lots: PN 260177, all lot codes.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1963-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1963-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1964-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1965-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02

Product code BZO

K945740Class IInfant Flow SystemHamilton Medical, Inc. / cleared 1995-03-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)