Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44140 (pack of 50), Pro

FDA device recall Z-1612-2014 · posted 2014-05-13 · Terminated

Recall details

Recalling firm

Medline Industries Inc

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.

Action taken

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.

Root cause

Process design

Status

Terminated

Product code

BYZ

Quantity affected

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.

Date initiated

2013-11-04

Date posted

2014-05-13

Date terminated

2017-11-29

Location

Mundelein, IL