ILGClass I

Stocking, Elastic

Physical Medicine · 21 CFR 890.3475

MDR events2All time

Recalls3All time

Registered firms103Currently listed

510(k) clearances8All time

Recent MDR events

2 adverse event reports on file

Event type breakdown

Unspecified1

Injury1

Most-reported manufacturers

*1 Hartmann Usa1

Recalls

3 recall events for this product code

Cardinal Health 200, LLC
TerminatedUnknown
In-View Clear Leggings Sterile
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.
Z-1300-2021 · View FDA record ↗
Cardinal Health 200, LLC
TerminatedUnknown
In-View Clear Leggings Sterile Non-Sterile
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.
Z-1301-2021 · View FDA record ↗
Cardinal Health 200, LLC
TerminatedUnknown
In-View Clear Leggings Bulk Non-Sterile
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.
Z-1302-2021 · View FDA record ↗

Registered firms

103 firms currently registered for this product code

510(k) clearances

8 clearances for this product code