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VIAL ADAPTER WITH FILTER
Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · Model VA-DF20L05 · UDI-DI 46975124931368
LHI
Prescription
1
510(k) clearances
14,401
Adverse events (20 deaths)
61
Recalls
173
Facilities
Description
The Vial adapter with filter consists of an interface, a housing, a membrane ring, a filter membrane and a puncture section; the interface, the housing and the puncture section are made of polycarbonate (PC), the membrane ring is made of polyethylene (PE) and the filter membrane is made of polyamide (PA) or acrylic (AA). The vial adapter with filter is indicated for the transfer and mixing of drugs contained in vials.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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. |
| 2022-07-14 | Baxter Healthcare Corporation | There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets. |
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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.