Device 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.
Z-1612-2014
Product summary
- Event
- Event 66775
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,610 mucus specimen traps
- Official record key
device-enforcement:Z-1612-2014
Official wording
Reason: 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.
Code information: Model Numbers: DYND44140, DYND44140H, and DYND44180; Purchase Order Number: 4506595929
Distribution pattern: US Nationwide Distribution in the states of CA, MA, MD, MI, MN, NH, NJ, NY, OH, PA, TX, and UT.
Derived failure modes
-
Unknown
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.