Home › YUKON MEDICAL, LLC › Arisure
Arisure
YUKON MEDICAL, LLC · Model YM061 · UDI-DI 00851891007308
LHI
Prescription
10
510(k) clearances
14,331
Adverse events (20 deaths)
61
Recalls
173
Facilities
Description
Arisure Bag Spike
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.