Vapotherm: Medical Device Recall in 2023 - (Recall #: Z-1272-2023)
See the recall detail below. You can also see other recalls from the same firm in 2023.
Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
Class II
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.
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
Worldwide distribution - US Nationwide and the country of UK.
Voluntary: Firm initiated