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U.S. Department of Health and Human Services

Class 2 Device Recall Vapotherm

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  Class 2 Device Recall Vapotherm see related information
Date Initiated by Firm August 13, 2014
Date Posted September 25, 2014
Recall Status1 Terminated 3 on October 02, 2015
Recall Number Z-2700-2014
Recall Event ID 69116
510(K)Number K072845  
Product Classification Humidifier, respiratory gas, (direct patient interface) - Product Code BTT
Product Vapotherm Precision Flow,Disposable Patient Circuit
PF-E-DPC-High. For use with the Precision Flow system

Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
Code Information Lot Numbers 1402021 through 1406010, excluding lots 1402024 through 1402028 and 1404003. These numbers are applicable regardless of the prefix preceding them (i.e. HF, HFE, HFH, HFN, LF, LFE, LFH or LFN).
Recalling Firm/
Manufacturer		 Vapotherm, Inc.
22 Industrial Dr Ste 1
Exeter NH 03833-4557
Manufacturer Reason
for Recall		 Disposable Patient Circuit that allows water to leak into the center gas lumen
FDA Determined
Cause 2		 Process control
Action 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
Quantity in Commerce 1005 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, kuwait, and Italy.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BTT and Original Applicant = VAPOTHERM, INC.
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