Home › Takeda Pharmaceuticals U.S.A., Inc. › HyHub Duo Vial Access Device
HyHub Duo Vial Access Device
Takeda Pharmaceuticals U.S.A., Inc. · Model 6520083 · UDI-DI 00850025688963
LHI
Prescription
1
510(k) clearances
14,401
Adverse events (20 deaths)
62
Recalls
172
Facilities
Description
The HyHub™ Duo Vial Access Device with two (2) docking stations is a stand-alone, single-use, disposable, non-pyrogenic, gamma sterilized device, which is intended to support the infusion of two medicinal liquids, as prescribed, in a home environment or clinical setting. HyHub Duo is designed to accommodate up to two (2) dual vial units (DVU) to be docked onto the HyHub Duo infusion tray which allows the transfer of medicinal liquids in a needleless, sequential method using standard connections for syringes, applicable pumps, and infusion sets.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-20 | ICU Medical, Inc. | Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, expo |
| 2025-02-20 | Omnicell, Inc. | IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during se |
| 2024-09-24 | West Pharmaceutical Services AZ, Inc. | Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier. |
| 2024-08-20 | Baxter Healthcare Corporation | Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H9 |
| 2024-08-20 | Baxter Healthcare Corporation | Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H9 |
| 2024-08-20 | Baxter Healthcare Corporation | Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H9 |
| 2024-08-20 | Baxter Healthcare Corporation | Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H9 |
| 2023-12-22 | Baxter Healthcare Corporation | An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in |
| 2023-12-22 | Baxter Healthcare Corporation | An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in |
| 2022-09-16 | International Medical Industries, Inc. | Blister package had an unsealed edge compromising sterility. |
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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.