ICU Medical NanoClave Connector 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 100 pouches of NanoClave Connectors because a manufacturing defect might prevent proper sealing with the spike. This could lead to improper use of the medical device.

Why it’s dangerous

The internal surface of the connector may have a defect that prevents it from sealing correctly with the spike. This could cause improper use of the medical device during procedures.

Who’s affected

Healthcare professionals using the NanoClave Connector for intravascular catheters are most at risk. The recall affects specific lots of the product.

How to tell if you have this one

Check the lot numbers on the pouch: 4549051 or 4447754. The product is sold in 100 pouches per case with a unique identifier (UDI) code.

Brand
ICU Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot numbers 4549051 or 4447754 on the pouch.
Contact Manufacturer
Reach out to ICU Medical for further instructions on the recall.

✎ GovInfoNow

Questions people ask

How many units are affected?

100 pouches of NanoClave Connectors (lots 4549051 and 4447754).

What is the hazard?

A potential manufacturing defect on the internal surface may inhibit proper sealing with the spike.

What should I do if I have this product?

Check the lot number and contact ICU Medical for instructions.

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-0182-2021 — ICU Medical ICU Medical

Hello,

I own a ICU Medical that is covered by recall Z-0182-2021 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-0182-2021 (July 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0182-2021 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 Connector; 1 unit per pouch, 100 multivac pouches per case;UDI

Lower-risk recall