Z-2701-2014 Class II Terminated
FDA device recall Z-2701-2014 was initiated by Vapotherm, Inc. on August 13, 2014 and is designated Class II. Reason for recall: Disposable Patient Circuit that allows water to leak into the center gas lumen The recall status is terminated (terminated October 2, 2015). Affected quantity: 635 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 1, 2014
- Initiation Date
- August 13, 2014
- Termination Date
- October 2, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 635 units
Product Description
Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox 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.
Reason for Recall
Disposable Patient Circuit that allows water to leak into the center gas lumen
Distribution Pattern
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.
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).