ICU Medical ChemoLock Vial Spike Recall: Burr Particulate Risk

Take action

Contact the company & request your remedy

Recalling firmICU Medical, Inc.951 Calle Amanecer · 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 ChemoLock Vial Spikes (REF CL- 80S) because one lot may contain burr particulate. This could lead to contamination during drug transfers, potentially causing harm to patients.

Why it’s dangerous

The ChemoLock Vial Spike is designed to prevent contamination during drug transfers. However, one specific lot (3757712) may contain burr particulate, which could lead to contamination of the drug solution.

Who’s affected

Healthcare professionals using the ChemoLock Vial Spikes for drug administration are most at risk. Patients receiving medication through these devices may be affected if the spikes contain burr particulate.

How to tell if you have this one

Check for the product name 'ChemoLock Vial Spike', model REF CL-80S, and lot number 3757712. This recall applies to one specific lot of the product.

Brand
ICU Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for the lot number 3757712 on the ChemoLock Vial Spike packaging.

✎ GovInfoNow

Questions people ask

Is this recall affecting all ChemoLock Vial Spikes?

No, this recall only affects the specific lot number 3757712.

How can I tell if my ChemoLock Vial Spike is affected?

Check the lot number on the packaging; if it is 3757712, it is affected.

What should I do if I have the affected lot?

The recall record does not specify a remedy for this lot.

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-0805-2019 — ICU Medical ICU Medical

Hello,

I own a ICU Medical that is covered by recall Z-0805-2019 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-0805-2019 (January 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0805-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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 icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the

Lower-risk recall