ICU Medical NanoClave Stopcock Recall: Potential Seal Failure Risk

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Contact the company & request your remedy

Recalling firmICU Medical, Inc.951 Calle Amanecer, N/A · San Clemente, CA 92673-6212

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

ICU Medical is recalling 50 NanoCl:ave pouches because a manufacturing defect might prevent the stopcock from sealing properly with the spike. This could lead to fluid leaks during medical procedures, which is serious for patients needing intravenous treatments.

Why it’s dangerous

The stopcock's internal surface has a manufacturing defect that may prevent it from sealing correctly with the spike. This could cause fluid leaks during medical procedures, potentially exposing patients to infection or complications.

Who’s affected

Healthcare professionals using the NanoClave stopcock for intravenous treatments are most at risk. Patients receiving IV fluids through this device could face leaks if the seal fails.

How to tell if you have this one

Check for the lot number 4572842 on the NanoClave stopcock packaging. The product comes in 50 pouches per case, with each pouch containing one stopcock unit.

Brand
ICU Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Seal Failure
Inspect the stopcock for signs of improper sealing with the spike, which may cause fluid leaks during use.

✎ GovInfoNow

Questions people ask

How many units are affected?

1 unit per pouch, 50 pouches per case (lot 4572842).

What is the hazard?

A potential manufacturing defect on the internal surface may prevent proper sealing with the spike, risking fluid leaks during medical procedures.

Is there a remedy?

The recall record does not specify a remedy.

Take action

Contact ICU Medical

We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0212-2021 — ICU Medical ICU Medical

Hello,

I own a ICU Medical that is covered by recall Z-0212-2021 from ICU Medical.

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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Where this comes from

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.

Official source: FDA Recall #Z-0212-2021 (July 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0212-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

ICU Medical, Inc. recalls NanoClave Stopcock w/NanoClave; 1 unit per pouch, 50 multivac pouches per case.

Use caution until it’s fixed