FDA Device Intelligence
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SampLok® Adapter Cap 3 Insert

ITL ASIA PACIFIC SDN. BHD. · Model A100763 · UDI-DI 09555240401557

JKA Prescription
1
510(k) clearances
49,073
Adverse events (3 deaths)
170
Recalls
221
Facilities

Description

SampLok® Adaptor Cap 3 (SAC 3) Insert is an optional accessory to be used with SAC 3 to facilitate collection of blood sample into vacuum tube(s). It 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.