FDA Device recall Z-1272-2023
Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
- FDA Device
- Class II
- ongoing
- Published 2023-03-29
On 2023-03-29 the FDA classified a Class II recall of Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW by Vapotherm, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1272-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-16 |
| Published | 2023-03-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Vapotherm |
| Distribution | US |
Product
Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW
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.
Identifiers
| code_info | UDI-DI: 00841737104971, Lot Numbers: LFVMA8503, LFVMA8504, LFVMA8567; UDI-DI: 00841737104978, Lot Number: LFVLE8568 A…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1272-2023%22
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