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Kawasumi

Jiangsu Caina Medical Co.,Ltd · Model 23Gx3/4"12" · UDI-DI 06971564467940

JKA Prescription
10
510(k) clearances
49,073
Adverse events (3 deaths)
170
Recalls
218
Facilities

Description

K-Shield Advantage® Winged Blood Collection Set with Pre-attached Holder

Recalls

DateFirmReason
2025-12-19ICU Medical Inc.Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
2025-09-26ASP Global, LLC. dba Anatomy Supply Partners, LLC.Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.

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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.