Recall Z-1272-2023 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Vapotherm
Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
| Date | Mar 17, 2023 (initiated Dec 16, 2022) |
| Status | Open, Classified |
| Reason | There have been reports of excessive condensation associated with certain lots of the Low Flow Disposable Patient Circuits (DPCs) used with Precision Flow System which may lead to excessive rainout. |
| Root cause | Nonconforming Material/Component |
| Action | A Technical Bulletin dated 10/27/22 was distributed to customers. Vapotherm has learned of certain Low Flow Disposable Patient Circuit (DPC) lots exhibiting excessive condensation. Please find the affected DPC lots in the attached appendix. You have been identified as a customer that received some or all of these lots. This condensation can be mitigated by ensuring that the delivery tube is fully primed and warm before placing the therapy on the patient, per existing instructions for use. Always check that the delivery tube is warm across the entire length before placing the therapy on the |
| Quantity | 5869 total |
| Distribution | Worldwide distribution - US Nationwide and the country of UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111640 | PRECISION FLOW(R) - HELIOX Vapotherm, Inc., Oct 7, 2011 |