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Orantech

Orantech Inc. · Model TNC-GPS-CTC-003 · UDI-DI 06941691969037

KCY
10
510(k) clearances
1,994
Adverse events (1 deaths)
111
Recalls
108
Facilities

Description

Reusable cylindrical tourniquet Cuffs,12"X3.5",single port,single bladder,dark purple

Recalls

DateFirmReason
2026-08-24ASP Global, LLC.Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is
2026-08-24ASP Global, LLC.Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is
2026-08-24ASP Global, LLC.Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is
2026-08-24ASP Global, LLC.Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is
2026-08-24ASP Global, LLC.Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is
2026-08-24ASP Global, LLC.Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is
2026-08-24ASP Global, LLC.Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is
2026-08-24ASP Global, LLC.Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is
2026-08-24ASP Global, LLC.Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is
2026-08-24ASP Global, LLC.Due to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The correct validated shelf life is

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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.