Reported Mar 18, 2020 · Terminated

BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The…

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?

  • BodyGuard Microset REF A120-003XYVA, Sterile EO
  • Tubing150 in. (380 cm)
  • Prime Volapprox. 8ml
  • Product UsageThe BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously
Lot codes and dates
  • Catalog NumberA120-003XYVA
  • UDI00818666020146
  • Lot Numbers
    • 10636
    • 10653
    • 12117
    • 12836
    • 13156
    • 13279
    • 13656
    • 13978
    • 14057
    • 14188
    • 14545
    • 14790
    • 14966
    • 15073
    • 19486
    • 19490
    • 19492
    • 19834
    • 16173
    • 14966
    • 15073
    • 15277
    • 15434
    • 15802
Amount recalled
69400 infusion sets

Where it was sold

Why it was recalled

Stop using this product now

When using a specific tubing set with infusion pump system, may result in under deliver of fluids.

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 Apr 13, 2022 · Data as of Sep 19, 6:57 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.