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Recall Observatory FDA recall evidence

Device product

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

Z-1272-2023

December 16, 2022

Class II

Product summary

Firm
Vapotherm
Event
Event 91579
Status
Ongoing
Classification
Class II
Quantity
5869 total
Official record key
device-enforcement:Z-1272-2023

Official wording

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.

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

Distribution pattern: Worldwide distribution - US Nationwide and the country of UK.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.