Reported Jul 22, 2020 · Terminated

CMExpress Microbore Set, REF: A120-160CRV

CME America, LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CME America, LLC · 14998 W 6th Ave Ste 830 · Golden, CO · 80401-5025

Is this the product you have?

  • CMExpress Microbore Set
  • REFA120-160CRV
Lot codes and dates
  • All lots within expiry
Amount recalled
402026

This recall covers 37 products

The agency filed one notice per product. You are reading one of them; the other 36 are below.

24 more are in the archive.

Where it was sold

Why it was recalled

Stop using this product now

Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 9, 2022 · Data as of Sep 19, 4:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.