Recall Z-1301-2021— Cardinal Health 200, LLC

Class II · Terminated

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2021-02-25, terminated 2024-01-09. FDA's recall record names no specific 510(k) clearance for this event. Product: In-View Clear Leggings Sterile Non-Sterile. Reason: Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly..

Recalling firm
Cardinal Health 200, LLC
Classification
Class II
Status
Terminated
Initiated
2021-02-25
Terminated
2024-01-09
Firm location
Waukegan, IL, United States

Product description

In-View Clear Leggings Sterile Non-Sterile

Reason for recall

Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.

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