Recall Z-2702-2014
Vapotherm, Inc. · initiated August 13, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into 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.
Codes / lots: 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).
Reason for recall
Disposable Patient Circuit that allows water to leak into the center gas lumen
FDA-determined cause: Process control
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
Details
- Recall number
- Z-2702-2014
- Initiated
- August 13, 2014
- Posted by FDA
- September 25, 2014
- Terminated
- October 2, 2015
- Product code
- BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
- Quantity
- 387 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.
- Recalling firm
- Vapotherm, Inc., Exeter, NH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2699-2014 Class II | Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the…Disposable Patient Circuit that allows water to leak into the center gas lumen | 08/13/2014Terminated |
| Z-2700-2014 Class II | Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the…Disposable Patient Circuit that allows water to leak into the center gas lumen | 08/13/2014Terminated |
| Z-2701-2014 Class II | Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the…Disposable Patient Circuit that allows water to leak into the center gas lumen | 08/13/2014Terminated |
| Z-2703-2014 Class II | Vapotherm Precision Flow,Disposable Patient Circuit PF-DPC-Low. For use with the…Disposable Patient Circuit that allows water to leak into the center gas lumen | 08/13/2014Terminated |
| Z-2704-2014 Class II | Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-Low. PF-DPC-Low packaged…Disposable Patient Circuit that allows water to leak into the center gas lumen | 08/13/2014Terminated |
| Z-2705-2014 Class II | Vapotherm Precision Flow,Disposable Patient Circuit PFHDPC-Low. For use with the Heliox…Disposable Patient Circuit that allows water to leak into the center gas lumen | 08/13/2014Terminated |
| Z-2706-2014 Class II | Vapotherm Precision Flow,Disposable Patient Circuit PF-NODPC-Low. For use with the…Water may leak into the center gas lumen of the Patient Circuit | 08/13/2014Terminated |