The Recall Desk
HighFDA (Devices)·Z-1612-2014·Announced 2014-05-21

Medline Mucus Specimen Traps Recalled for Potential Sterility Issues

Medline Industries is recalling 1,610 mucus specimen traps because they may not be sterile, which could contaminate patient specimens.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where the hazard is a risk of harm (specimen contamination) without reported illness or injury, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Medline Industries Inc is recalling 1,610 mucus specimen traps, including 40 cc and 80 cc models, due to a potential lack of sterility. The affected products are used to collect mucus specimens during suction procedures from the oral cavity, nose-throat area, and bronchi.

The recall is being conducted because the specified mucus specimen traps may not be sterile. The use of these affected products may result in the contamination of patient specimens.

The products were distributed nationwide in the states of California, Massachusetts, Maryland, Michigan, Minnesota, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Texas, and Utah. Healthcare facilities and consumers should stop using the affected products and contact Medline Industries for further instructions.

The recalled product

Product
Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44140 (pack of 50), Product number DYND44140H (individual). Mucus Specimen Trap 80 cc, Specimen Trap 80 cc w/ additional transport cap; Product number DYND44180 (pack of 50). Us
Affected units
1,610

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Model Numbers: DYND44140
  • DYND44140H
  • and DYND44180
  • Purchase Order Number: 4506595929

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically: