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

Hazard

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.

Details from the source

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. Distribution: Worldwide distribution - US Nationwide and the country of UK. Quantity: 5869 total Lot/code info: 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

UPC codes

00841737104971, 00841737104978

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.