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Tournisec

62K SOLUTIONS, LLC · Model KFG112 · UDI-DI 00199874682402

ILG
8
510(k) clearances
2
Adverse events
3
Recalls
96
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. Large size (12" width). Waist size > or = 36".

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

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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.