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
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
- Device type
- Other Medical Devices
Timeline
| 4 Nov 2013 | Recall initiated by company | |
| 13 May 2014 | Classified by FDA | +190 days |
| 21 May 2014 | Published 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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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
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