CLASS II Device recall · Reported 21 May 2014 · FDA Enforcement Report

Mucus Specimen Trap 40 cc, Specimen Trap 40 cc recalled

Medline Industries is recalling Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap, distributed nationwide in the US. The recall was initiated on 4 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Numbers: DYND44140, DYND44140H, and DYND44180; Purchase Order Number: 4506595929
Quantity recalled1,610 mucus specimen traps

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1612-2014
FDA event ID
66775
Recalling firm
Medline Industries, Mundelein, IL
Classification
Class II
Status
Terminated
Recall initiated
4 Nov 2013
FDA classified
13 May 2014
Reported
21 May 2014
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

4 Nov 2013Recall initiated by company
13 May 2014Classified by FDA+190 days
21 May 2014Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential that the specified mucus specimen traps are not sterile. Use of the affected products may result in the contamination of patient specimens.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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). Used to collect mucus specimens during suction of fluid from the oral cavity, nose-throat area and/or bronchi of a patient.

Where it was distributed

US Nationwide Distribution in the states of CA, MA, MD, MI, MN, NH, NJ, NY, OH, PA, TX, and UT.

Nationwide CaliforniaMassachusettsMarylandMichiganMinnesotaNew HampshireNew JerseyNew YorkOhioPennsylvaniaTexasUtah

Questions about this recall

Is Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap recalled?

Yes. Medline Industries recalled Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap on 4 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-1612-2014.

Why was it recalled?

There is a potential that the specified mucus specimen traps are not sterile. Use of the affected products may result in the contamination of patient specimens.

Which lots are affected?

Model Numbers: DYND44140, DYND44140H, and DYND44180; Purchase Order Number: 4506595929

Where was it sold?

US Nationwide Distribution in the states of CA, MA, MD, MI, MN, NH, NJ, NY, OH, PA, TX, and UT.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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