Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
FDA Recall #Z-1272-2023 — Class II — December 16, 2022
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.
Recalling Firm
Vapotherm — Exeter, NH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
5869 total
Distribution
Worldwide distribution - US Nationwide and the country of UK.
Code Information
UDI-DI: 00841737104971, Lot Numbers: LFVMA8503, LFVMA8504, LFVMA8567; UDI-DI: 00841737104978, Lot Number: LFVLE8568 Additional Lot Numbers: LFTL41015 LFVLC8399 LFVLE8495 LFVMA8502 LFVMA8503 LFVMA8504 LFVMA8567 LFTL41261 LNTL41544 LFVLE8588 LFVMA8507 LFVLE8568 LFVLE8494 LFTL41263 LFTL41262
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated