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KIRO Oncology US

KIRO GRIFOLS SL. · Model 1008US · UDI-DI 08437014572209

NEP

510(k) clearances

1,226

Adverse events (7 deaths)

Recalls

Facilities

Description

KIRO Oncology is an automated pharmacy compounding device (PCD) for the preparation of compounded sterile preparations (CSPs). KIRO Oncology includes an automated cleaning system for decontamination of the compounding area. The device is intended to be used only by qualified pharmacy personnel.

Recalls

Date	Firm	Reason
2026-04-22	Baxter Healthcare Corporation	Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slow
2026-03-25	Omnicell, Inc.	Potential for mislabeled syringe produced by the i.v.STATION device.
2023-03-27	OmniCell, Inc.	IVX Station does not account for inherent scale inaccuracy or variability, could result in a preparation being passed that is outside of the dose accuracy stated in the product lab
2022-06-22	Baxter Healthcare Corporation	There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
2021-03-31	Smiths Medical ASD Inc.	Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. Th
2021-03-31	Smiths Medical ASD Inc.	Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. Th
2020-11-23	B Braun Medical, Inc.	There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an
2020-11-23	B Braun Medical, Inc.	There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an
2020-11-23	B Braun Medical, Inc.	There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an
2018-06-04	B. Braun Medical, Inc.	There is a potential for valves on the 26-Lead Transfer Set to be incorrectly oriented. When a transfer set with an incorrectly oriented valve is installed on the system, there i

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Data 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.