ICU Medical NanoClave Sets May Not Seal Properly

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

ICU Medical is recalling 50 pouches of NanoCl: 226 cm (89 in) MicroClave Clear sets that may not seal properly with the spike. This could lead to improper fluid administration and infection risks.

Why it’s dangerous

The internal surface of the NanoClave may have a manufacturing defect that prevents it from sealing correctly with the spike. This could allow contaminants to enter the patient's bloodstream during fluid administration, increasing infection risk.

Who’s affected

Healthcare professionals using these sets for patient fluid administration. Patients receiving treatments through these sets are at risk of infection if the seal fails.

How to tell if you have this one

Check for the UDI code (01)10840619061231(17)250201(30)50(10)4734990 on the packaging. The product is a 226 cm (89 in) MicroClave Clear set with 1 unit per pouch, 50 pouches per case.

Brand
ICU Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the UDI code (01)10840619061231(17)250201(30)50(10)4734990 on the packaging.

✎ GovInfoNow

Questions people ask

What is the specific defect in the NanoClave sets?

The internal surface may have a manufacturing defect that prevents proper sealing with the spike.

How many units are affected?

50 pouches per case, with one unit per pouch.

What should I do if I have this product?

Check the product label for the UDI code; if it matches, 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-0275-2021 — ICU Medical ICU Medical

Hello,

I own a ICU Medical that is covered by recall Z-0275-2021 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-0275-2021 (July 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0275-2021 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 226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1 unit per pouch, 50 pouches per case. UDI:

Use caution until it’s fixed