Z-1612-2014Class II

Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44140 (pack...

Name: Z-1612-2014 Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44140 (pack...
Creator: Medline Industries Inc
Published: 2013-11-04
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2013-11-04 / Terminated / root cause: manufacturing process

FDA source

Medline Industries Inc began a recall of Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44140 (pack of 50), Product number DYND44140H (individual)... on 2013-11-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1612-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-04
Posted: 2014-05-13
Terminated: 2017-11-29
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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). Used to collect mucus specimens during suction of fluid from the oral cavity, nose-throat area and/or bronchi of a patient.
Product code: BYZ Trap, Sterile Specimen
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Medline sent a Recall Notification Letters dated November 4, 2013 to all affected customers.The letters included instructions for customers to: check their stock of the affected products; complete and return the enclosed response form even if none of the recalled products are in inventory; Medline will provide customers with a Return Goods Authorization upon receipt of the response form and credit will be issued upon receipt of the returned recalled products; and, notify any customers who may have received the recalled products. Customers who have any questions can contact Medline Industries at 866-359-1704.
Quantity in commerce: 1,610 mucus specimen traps
Distribution: US Nationwide Distribution in the states of CA, MA, MD, MI, MN, NH, NJ, NY, OH, PA, TX, and UT.
Product codes and lots: Model Numbers: DYND44140, DYND44140H, and DYND44180; Purchase Order Number: 4506595929

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1612-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1612-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-13

Product code BYZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)