Low Flow Disposable Patient Circuit for the Precision recall
Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
Why was Low Flow Disposable Patient Circuit for the Precision 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
- Recalling firm
- Vapotherm
- Quantity
- 5869 total
- Distribution
- Worldwide distribution - US Nationwide and the country of UK.
- Recall date
- March 29, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)