Home › SB-KAWASUMI LABORATORIES, INC. › K-SHIELD Zen Winged Blood Collection Set with Pre-attached Holder
K-SHIELD Zen Winged Blood Collection Set with Pre-attached Holder
SB-KAWASUMI LABORATORIES, INC. · Model PBMH-25G · UDI-DI 04987488091217
JKA
Prescription
10
510(k) clearances
49,073
Adverse events (3 deaths)
170
Recalls
221
Facilities
Description
K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti-needle stick protector is an integral safety device intended to minimize accidental needlestick injuries.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-19 | ICU 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 |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP Global, LLC. dba Anatomy Supply Partners, LLC. | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. |
| 2025-09-26 | ASP 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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Get your free API keyRead the docsData 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.