Reported Dec 4, 2019 · Terminated

4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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: Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. · 87 Venture Dr · Dover, NH · 03820-5914

Is this the product you have?

  • 4Fr x 20cm Single Lumen CT Midline Basic Tray
  • Product CodeVYML4S1001
Lot codes and dates
  • Product CodeVYML4S1001
  • Lot Number17B012D Exp
  • Date2021-10-31
Amount recalled
75

Where it was sold

Why it was recalled

Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 21, 2020 · Data as of Sep 19, 4:48 PM UTC

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