Skip to content

Low Flow Disposable Patient Circuit for the Precision Flow… recallZ-1272-2023 · Vapotherm · initiated Dec 16, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Vapotherm or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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

Recall details

Recall number
Z-1272-2023
Status
Open, Classified
Initiated by the company
Dec 16, 2022
Posted by the FDA
Mar 17, 2023
Recalling firm
Vapotherm
Quantity
5869 total
Product code
BTT
FDA submissions
K111640
Distribution
Worldwide distribution - US Nationwide and the country of UK.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page