FDA Device Intelligence
Home62K SOLUTIONS, LLC › Tournisec

Tournisec

62K SOLUTIONS, LLC · Model KFG108 · UDI-DI 00199874723976

ILG
8
510(k) clearances
2
Adverse events
3
Recalls
97
Facilities

Description

10 Pack - Disposable, non-sterile, single use, form fitting, stockinette worn by patient that acts as padding and method of securing a pneumatic tourniquet at the thigh. Regular size. Width 8". Waist size < or = 35".

Recalls

DateFirmReason
2021-02-25Cardinal Health 200, LLCCardinal 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 th
2021-02-25Cardinal Health 200, LLCCardinal 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 th
2021-02-25Cardinal Health 200, LLCCardinal 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 th

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.