FDA Device Intelligence
Home › ICU MEDICAL, INC. › ICU Medical, Inc.

ICU Medical, Inc.

ICU MEDICAL, INC. · Model DS1030-24-01 · UDI-DI 00887709166318

NEP Prescription
0
510(k) clearances
1,226
Adverse events (7 deaths)
41
Recalls
52
Facilities

Description

GTIN for DS1030-24-01, 1/EA

Recalls

DateFirmReason
2026-04-22Baxter Healthcare CorporationAffected 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
2026-03-25Omnicell, Inc.Potential for mislabeled syringe produced by the i.v.STATION device.
2023-03-27OmniCell, 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
2022-06-22Baxter Healthcare CorporationThere is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
2021-03-31Smiths 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
2021-03-31Smiths 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
2020-11-23B 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
2020-11-23B 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
2020-11-23B 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
2018-06-04B. 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

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 docs
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.