5 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer
FDA Enforcement
Class I
·Terminated·ARROW INTERNATIONAL Inc.·December 21, 2022
BD Alaris PCU REF 8015
FDA Enforcement
Class I
·Ongoing·CareFusion 303, Inc.·November 15, 2023
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
FDA Enforcement
Class I
·Ongoing·CareFusion 303, Inc.·March 19, 2025
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
FDA Enforcement
Class I
·Ongoing·CareFusion 303, Inc.·March 19, 2025
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015