Precision Flow and Nitric Oxide Ready - Disposable Patient Circuit (2014-08-13)

Starting date:

August 13, 2014

Posting date:

September 3, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-41241

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  Reason
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  Affected products

Recalled Products

A) Precision Flow - Disposable Patient Circuit

B) Precision Flow - Disposable Patient Circuit (PF-E-DPC High Evaluation)

C) Nitric Oxide Ready Disposable Patient Circuit LOW

Reason

Vapotherm is recalling multiple lots of the Vapotherm precision flow disposable patient circuit. Between May 12, 2014 and August 7, 2014 there were 7 reports for 11 disposable patient circuits from the field of water in the outer lumen entering the gas path lumen of the delivery tube. Initial investigation of complaint returns has determined that there is likely insufficient solvent bonding between the tube and disposable water path connector on the delivery tube. This is allowing water from the outer lumens to enter the center lumen at the connector.

Affected products