Vapotherm recalls Low Flow Disposable Patient Circuits with certain lot numbers due to excessive condensation causing rainout. Affected units may require replacement to prevent moisture buildup.
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.
Vapotherm is recalling specific low-flow disposable patient circuits for their Precision Flow System because some models cause excessive condensation, which can lead to rainout. This means moisture buildup might interfere with medical equipment function.
Excessive condensation in the patient circuits can cause rainout, which is moisture buildup that may interfere with the medical device's operation. This could lead to equipment malfunction or reduced effectiveness during use.
Healthcare providers using the Precision Flow System with the recalled patient circuits are most at risk. Patients using these circuits could experience equipment malfunction due to moisture buildup.
Check for lot numbers listed: LFVMA8503, LFVMA8504, LFVMA8567, LFVLE8568, LFTL41015, LFVLC8399, LFVLE8495, LFVMA8502, LFVMA8507, LFVLE8568, LFVLE8494, LFTL41261, LNTL41544, LFVLE8588, LFTL41263, LFTL41262.
Look for the lot number on the circuit packaging or label to determine if it is affected.
Excessive condensation in certain lots can cause rainout, which may lead to moisture buildup that interferes with the medical device's operation.
Affected lot numbers include LFVMA8503, LFVMA8504, LFVMA8567, LFVLE8568, LFTL41015, LFVLC8399, LFVLE8495, LFVMA8502, LFVMA8507, LFVLE8568, LFVLE8494, LFTL41261, LNTL41544, LFVLE8588, LFTL41263, LFTL41262.
No, the recall does not require immediate stop use. Affected units may be replaced without stopping use.
We’ve drafted a message you can send Vapother: 1.1.1 to request your refund or repair — edit it as you like.
Subject: Recall Z-1272-2023 — Vapother: 1.1.1 Vapother: 1.1.1 Hello, I own a Vapother: 1.1.1 that is covered by recall Z-1272-2023 from Vapother: 1.1.1. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
