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KENAFLEXX
KENTRON HEALTHCARE, INC. · Model 950020 · UDI-DI 00852244007877
LHI
Prescription
10
510(k) clearances
14,401
Adverse events (20 deaths)
62
Recalls
172
Facilities
Description
20" IV EXTENSION SET WITH FEMALE LUER AND ROTATING MALE LUER LOCK, FLOW BCONTROLLER AND THREE WAY STOP COCK.
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.