Recall Z-1272-2023— Vapotherm

Name: FDA recall Z-1272-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-16

Class II · Ongoing

Class II FDA medical device recall by Vapotherm, initiated 2022-12-16. It names one FDA 510(k) clearance: K111640. Product: Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW. 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..

Recalling firm: Vapotherm
Classification: Class II
Status: Ongoing
Initiated: 2022-12-16
Firm location: Exeter, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K111640 — PRECISION FLOW(R) - HELIOXVapotherm, Inc.·cleared 2011-10-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.