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U.S. Department of Health and Human Services

Class 2 Device Recall Specimen Trap

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 Class 2 Recall
Specimen Trap
see related information
Date Posted May 13, 2014
Recall Status1 Open
Recall Number Z-1612-2014
Recall Event ID 66775
Product Classification Trap, Sterile Specimen - Product Code BYZ
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.
Code Information Model Numbers: DYND44140, DYND44140H, and DYND44180; Purchase Order Number: 4506595929
Recalling Firm/
Manufacturer
Medline Industries Inc
1 Medline Pl
Mundelein, Illinois 60060-4485
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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