GRI-FILL 6 to1 Set
LABORATORIOS GRIFOLS SA · Model - · UDI-DI 08426314778770
Description
Fluid transfer set consisting of PVC tubing linking 6 mini-spikes to be used in conjunction with 2 ways transfer set through which the same substance from up to 6 rubber-stoppered glass vials may be delivered into a final IV container. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the source substances. The spike on each line facilitates easy puncture of thick rubber stoppers of small diameter. The device provides fast fluid addition and extraction due to the large surface area of the air-filter that quickly equalizes pressures.
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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