Z-1272-2023Class II

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

Name: Z-1272-2023 Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
Creator: Vapotherm
Published: 2022-12-16
License: https://open.fda.gov/license/

Vapotherm Inc. / initiated 2022-12-16 / Open, Classified / root cause: manufacturing process

FDA source

Vapotherm began a recall of Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW on 2022-12-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1272-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-16
Posted: 2023-03-17
Recalling firm: Vapotherm Inc.
Product: Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
Product code: BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A Technical Bulletin dated 10/27/22 was distributed to customers. Vapotherm has learned of certain Low Flow Disposable Patient Circuit (DPC) lots exhibiting excessive condensation. Please find the affected DPC lots in the attached appendix. You have been identified as a customer that received some or all of these lots. This condensation can be mitigated by ensuring that the delivery tube is fully primed and warm before placing the therapy on the patient, per existing instructions for use. Always check that the delivery tube is warm across the entire length before placing the therapy on the patient. If you experience delivery tubes that are not circulating water or are cold, do not use. Please contact Vapotherm Technical Support to report the issue. For every incident reported, we will replace and ship out a new DPC as soon as possible at no cost to you. Thank you for your continued support of Vapotherm and providing your patients with optimal care. If you have any questions, please contact Vapotherm Technical Support: For US customers, [email protected] or 855 557 8276 For UK customers, [email protected] or +44 0345 305 8098 For all other customers, please reach out to your Vapotherm distributor. An Urgent Field Safety Notice dated 12/16/22 was sent to customers in the UK. Vapotherm requests that you return any unused products of the lots detailed below. Unused products from the affected lots should be returned as described in the Required Actions section within the FSN. This product removal is limited to the product codes / lot numbers listed below. No other product codes or lot numbers are affected. Required Actions to be taken by the VAPOTHERM: 1.For any unused product of the affected lots, replace affected DPC lots. 2.Email Customer Acknowledgment Form to impacted customers. 3.Ensure completion of Customer Acknowledgement Form. Required Actions to be taken by the END USER/ HEALTHCARE ORGANIZATION: 1.Inspect your inventory, locate any unused units of the af
Quantity in commerce: 5869 total
Distribution: Worldwide distribution - US Nationwide and the country of UK.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1272-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1272-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-29	2023-03-17

Product code BTT

K111640Class IIPrecision Flow(r) - HelioxVapotherm, Inc. / cleared 2011-10-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)