Z-1612-2014 Class II Terminated
FDA device recall Z-1612-2014 was initiated by Medline Industries Inc on Nov 4, 2013 and is designated Class II. 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. The recall status is terminated (terminated Nov 29, 2017). Affected quantity: 1,610 mucus specimen traps.
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2014
- Initiation Date
- Nov 4, 2013
- Termination Date
- Nov 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,610 mucus specimen traps
Product Description
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.
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.
Distribution Pattern
US Nationwide Distribution in the states of CA, MA, MD, MI, MN, NH, NJ, NY, OH, PA, TX, and UT.
Code Information
Model Numbers: DYND44140, DYND44140H, and DYND44180; Purchase Order Number: 4506595929
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1612-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026