Accessories, Pump, Infusion
General Hospital · 21 CFR 880.5725
Recent MDR events
537 adverse event reports on file
- SPECTRUM WIRELESS BATTERYJul 10, 2026MalfunctionBaxter Healthcare Corporation1314492-2026-01535
- SPECTRUM WIRELESS BATTERYJul 10, 2026MalfunctionBaxter Healthcare Corporation1314492-2026-01536
- SPECTRUM WIRELESS BATTERYJul 10, 2026MalfunctionBaxter Healthcare Corporation1314492-2026-01537
- POUCH UNIVRSAL 250-500 FANNYFeb 2, 2026MalfunctionMckessonMW5183152
- ACCESSORIES, PUMP, INFUSIONNov 21, 2025InjuryElite Biomedical Solutions Llc.MW5179302
- CADD SOLIS COMM MODULESep 2, 2025MalfunctionIcu Medical, Inc.3012307300-2025-10159
- CADD SOLIS COMM MODULEJul 25, 2025MalfunctionIcu Medical, Inc3012307300-2025-08941
- CADD SOLIS COMM MODULEJul 14, 2025MalfunctionIcu Medical, Inc.3012307300-2025-08333
- CADD SOLIS COMM MODULEJul 14, 2025MalfunctionIcu Medical, Inc.3012307300-2025-08334
- CADD SOLIS COMM MODULEJun 23, 2025MalfunctionIcu Medical, Inc.3012307300-2025-07510
Event type breakdown
Recalls
8 recall events for this product code
- Smiths Medical ASD Inc.Open, ClassifiedApr 15, 2024
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716
Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
Z-1543-2024 · View FDA record ↗ - Animas CorporationTerminatedDec 3, 2009
Animas ezManager Max Diabetes Management System version 2.0.9
Printed hard copy of results is not the same as the system screens- carbohydrate to insulin ratio incorrect.
Z-0481-2010 · View FDA record ↗ - ICU Medical IncTerminatedUnknown
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Sit
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0127-2020 · View FDA record ↗ - ICU Medical IncTerminatedUnknown
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbor
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0130-2020 · View FDA record ↗ - ICU Medical IncTerminatedUnknown
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Stripe
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0145-2020 · View FDA record ↗ - ICU Medical IncTerminatedUnknown
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yello
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0146-2020 · View FDA record ↗ - ICU Medical IncTerminatedUnknown
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yello
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Z-0147-2020 · View FDA record ↗ - ICU Medical IncTerminatedUnknown
SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02
There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
Z-0619-2019 · View FDA record ↗
Registered firms
55 firms currently registered for this product code
Meditera Tibbi Malzeme Sanayi Ve Ticaret A.s.
Tire Izmir, TR
Isomedix Operations Inc.
SPARTANBURG, SC, US
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
Cane' S.p.a.
RIVOLI-CASCINE VICA Torino, IT
Medtronic Minimed
NORTHRIDGE, CA, US
Intelimas Corporation
Londonderry, NH, US
Ivwatch, Llc
Newport News, VA, US
Infusystem Inc.
Lenexa, KS, US
Isomedix Operations Inc
EL PASO, TX, US
Icu Medical Costa Rica Ltd.
La Aurora de Heredia, CR
Tandem Diabetes Care, Inc.
San Diego, CA, US
Icu Medical, Inc.
Lake Forest, IL, US
Optum Distribution Center, Llc
Marietta, GA, US
Fresenius Vial S.a.s.
Brezins Isere, FR
Welldoc
Columbia, MD, US
Eitan Medical Ltd
Netanya Central, IL
B. Braun Melsungen Ag
MELSUNGEN Hesse, DE
Synergy Health Ast, Srl
Alajuela, CR
American I.v. Products, Inc.
HARMANS, MD, US
510(k) clearances
48 clearances for this product code
- Gilero, LLCJun 15, 2023
K230718 · UTC 3mL Medication Cartridge
- Elite Biomedical SolutionsApr 29, 2022
K220695 · Elite Biomedical Solutions Dose Request Cord
- Chengdu Shifeng Medical Technology Co., Ltd.Mar 26, 2021
K201634 · RG 3ml Medication Cartridge
- Welldoc, Inc.Apr 7, 2020
K193654 · BlueStar Rx
- B. Braun Melsugen AGMar 12, 2020
K191910 · SpaceStation MRI
- Welldoc, Inc.Nov 4, 2019
K190013 · WellDoc BlueStar
- B.Braun Medical, Inc.Aug 2, 2018
K173531 · Lockbox for Perfusor Space PCA Infusion Pump
- Icu MedicalAug 25, 2017
K171346 · Sapphire Sets