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HomeANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD › Multi-Sample Blood Collection Set

Multi-Sample Blood Collection Set

ANHUI HONGYU WUZHOU MEDICAL MANUFACTURER CO LTD · Model 21G x 3/4" · UDI-DI 06958697602974

JKA
1
510(k) clearances
49,073
Adverse events (3 deaths)
170
Recalls
219
Facilities

Description

A sharp bevel-edged, hollow tubular metal instrument intended to be used as part of a blood collection set for drawing blood from a patient. It is intended to be connected to blood collection tubing and/or a blood collection Luer connector for transfer into a blood specimen receptacle. It may include a pre-attached blood collection tube spike however it does not include a blood collection tube holder. This is a single-use device.

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.