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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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).…
- Manufacturer
- Medline Industries Inc
- Hazard
- 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
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