Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox Precision Flow system Precision

FDA device recall Z-2705-2014 · posted 2014-09-25 · Terminated

Recall details

Recalling firm

Vapotherm, Inc.

Reason for recall

Disposable Patient Circuit that allows water to leak into the center gas lumen

Action taken

Vapotherm issued an Initial Notification on August 13, 2014. The letter was updated on August 20, 2014 to include two additional lots. The recall letter notified users that this defect is easily detectable during normal use and the probability of serious injury or death is remote. The letter was sent to raise awareness of the recent increase in incidence rate of this issue and reminded users of the requirement in the operating manual that requires that the cannula be connected to the patient only after the set temperature is reached. The letter also advised patient care personnel not to use, or to discontinue use of any Disposable Patient Circuit if water is observed leaking into the center lumen or from the cannula. They were instructed to replace the device and report the defect to Vapotherm immediately for further investigation. Should you have any questions please contact our technical support team at Email: ts@vtherm.com (US) 855.557.8276 (INTL) 1-603.658.5121

Root cause

Process control

Status

Terminated

Product code

BTT

Quantity affected

865 units

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Canada, France, Swizerland, Korea, Sweden, Germany , Belgium, Spain, Mexico, Scotland, UAE, Australia, Israel, Hong Kong, Ireland, kuwa

Date initiated

2014-08-13

Date posted

2014-09-25

Date terminated

2015-10-02

Location

Exeter, NH

Related 510(k) clearances