—#123381

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.

FDA product code: BYZ — Trap, Sterile Specimen
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Model Numbers: DYND44140, DYND44140H, and DYND44180; Purchase Order Number: 4506595929

Why it was 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.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Medline Industries Inc
Address: 1 Medline Pl, Mundelein, Illinois 60060-4485

Distribution

Distribution pattern: US Nationwide Distribution in the states of CA, MA, MD, MI, MN, NH, NJ, NY, OH, PA, TX, and UT.

Timeline

Recall initiated: 2013-11-04
Posted by FDA: 2014-05-13
Terminated: 2017-11-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #123381. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.