ICU Medical NanoClave Connector Recall: Potential Seal Failure

Take action

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 that contain specific lot numbers. This recall is due to a potential manufacturing defect that could prevent the connector from sealing properly with the spike, which might lead to improper fluid administration during medical procedures.

Why it’s dangerous

The connector's internal surface may have a manufacturing defect that prevents it from sealing correctly with the spike. This could lead to improper fluid administration during medical procedures if the seal fails.

Who’s affected

Healthcare professionals using the NanoClave Connector for administering fluids to patients. The risk is low as the defect is specific to certain lot numbers and does not cause immediate harm.

How to tell if you have this one

Check the lot numbers: 4559476, 4711354, 4476111, 4493213, 4510900, or 4749152. The product is sold in pouches with 1 unit per pouch and 100 pouches per case.

Brand
ICU Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Identify if your NanoClave Connector has one of the lot numbers: 4559476, 4711354, 4476111, 4493213, 4510900, or 4749152.

✎ GovInfoNow

Questions people ask

What is the potential risk of this defect?

The defect may prevent the connector from sealing properly with the spike, which could lead to improper fluid administration during medical procedures.

How many units are affected?

100 pouches, each containing 1 unit of NanoClave Connector, with specific lot numbers listed in the recall.

Is there a remedy for this issue?

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-0263-2021 — ICU Medical ICU Medical

Hello,

I own a ICU Medical that is covered by recall Z-0263-2021 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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-0263-2021 (July 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0263-2021 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.

Lower-risk recall