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Smiths Medical ASD, Inc.

FDA Regulatory Profile

Summary

Total Recalls
293 (84 Class I)
510(k) Clearances
52
Inspections
26
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1662-2025Class ICADD Solis HSPCA PumpApril 10, 2025
Z-1681-2025Class ICADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, MApril 10, 2025
Z-1667-2025Class ICADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CAApril 10, 2025
Z-1682-2025Class ICADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISHApril 10, 2025
Z-1668-2025Class ICADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-212April 10, 2025
Z-1404-2025Class IICAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100February 14, 2025
Z-1405-2025Class IICAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214February 14, 2025
Z-1283-2025Class Ismiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.DFebruary 13, 2025
Z-1279-2025Class Ismiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8February 13, 2025
Z-1288-2025Class Ismiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.February 13, 2025
Z-1282-2025Class Ismiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane CathetFebruary 13, 2025
Z-1287-2025Class Ismiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9February 13, 2025
Z-1278-2025Class Ismiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm IFebruary 13, 2025
Z-1286-2025Class Ismiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24February 13, 2025
Z-1284-2025Class Ismiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane CathetFebruary 13, 2025
Z-1277-2025Class Ismiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm IFebruary 13, 2025
Z-1289-2025Class IPortex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100February 13, 2025
Z-1285-2025Class Ismiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane CathetFebruary 13, 2025
Z-1281-2025Class Ismiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8February 13, 2025
Z-1280-2025Class Ismiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) OFebruary 13, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeMay 31, 2024
K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl November 26, 2021
K211634Hypodermic Needle-Pro EDGE Safety DeviceAugust 26, 2021
K192375Intellifuse Administration and Intellifuse Blood Administration SetsSeptember 18, 2020
K181699Level 1 Convective WarmerJuly 26, 2018
K172800Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles withJune 14, 2018
K172823Portex NRFit Epidural NeedlesJune 12, 2018
K172410Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.)June 1, 2018
K172592CADD Yellow High Volume Administration Set with NRFit connectorMay 17, 2018
K173912BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation TrMay 8, 2018
K171968EchoGlo NeedleJanuary 25, 2018
K170720Portex Blue Line Ultra Paediatric Tracheosomy TubeDecember 7, 2017
K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood SNovember 9, 2017
K162219CADD® Infusion Disposables Portfolio with NRFit™ connectorsJuly 20, 2017
K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood SMay 24, 2017
K160235ViaValve Safety I.V. CatheterJune 30, 2016
K141193MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0July 25, 2014
K130394CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0December 9, 2013
K111275CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWAREFebruary 1, 2013
K110053CORRECTINJECT SAFETY SYSTEM, CATHETER CONNECTOR, FILTER, INFUSION ADAPTOR, SYRINGE KITSeptember 14, 2012