Recall Z-0780-2021— Medline Industries Inc

Name: FDA recall Z-0780-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-13

Class II · Terminated

Class II FDA medical device recall by Medline Industries Inc, initiated 2020-11-13, terminated 2021-10-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.. Reason: The cylindrical sponge component is not x-ray detectable..

Recalling firm: Medline Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2020-11-13
Terminated: 2021-10-26
Firm location: Northfield, IL, United States

Product description

Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of convenience kit used in various surgeries including cardiac, abdominal, and neck surgeries.

Reason for recall

The cylindrical sponge component is not x-ray detectable.

Data sourced from openFDA. This site is unofficial and independent of the FDA.