Reported Mar 29, 2023 · Ongoing
Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
Vapotherm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Vapotherm · 100 Domain Dr · Exeter, NH · 03833-4801
Is this the product you have?
- Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 00841737104978Lot Numbers: LFVMA8503, LFVMA8504, LFVMA8567; UDI-DI: 00841737104978 2 Lot Number: LFVLE8568 Additional 3 Lot Numbers: LFTL41015 LFVLC8399 LFVLE8495 LFVMA8502 LFVMA8503 LFVMA8504 LFVMA8567 LFTL41261 LNTL41544 LFVLE8588 LFVMA8507 LFVLE8568 LFVLE8494 LFTL41263 LFTL41262 - Amount recalled
- 5869 total
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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