| Class 2 Device Recall Specimen Trap | |
Date Initiated by Firm | November 04, 2013 |
Date Posted | May 13, 2014 |
Recall Status1 |
Terminated 3 on November 29, 2017 |
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 IL 60060-4485
|
For Additional Information Contact | 866-359-1704 |
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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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