Reported Sep 2, 2015 · Terminated

Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on…

Medline Industries 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: Medline Industries Inc · 1 Medline Pl · Mundelein, IL · 60060-4485

Is this the product you have?

  • Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the arm or chest through the skin into a large vein. The catheter is threaded through this vein until it reaches a large vein near the heart.
Lot codes and dates
  • Central Venous Catheter Kit for patients >34 weeks old with the coding below were affected
  • Lot Numbers14DB9277
  • and 14PB2878 Unit NoDYNDC1987A
  • Expiration Date06/2015
  • Serial NoN/A
  • UPC codeN/A
Amount recalled
320 units for lot 14DB9277 & 320 units for lot 14PB2878

Where it was sold

Why it was recalled

The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect sign in front of the 34. The description for this device should have stated Central Line >34 Weeks Kit. The defect may lead to the product to be used on patient population that is <34 weeks rather than intended population of >34 weeks.

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 Jan 5, 2017 · Data as of Sep 19, 5:29 PM UTC

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