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All Recalls

Every Smiths Medical Asd Inc. Recall

Sorted by most recent. Click any recall for full details.

182 recalls
High RiskFDA
Smiths Medical Asd Inc.
Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressur...
Medical Devices·11,340 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
Left Heart Kit, Model Number M20268. for blood pressure monitoring.
Cardiac Devices·600 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Mo...
Medical Devices·3,825 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
Medical Devices·200 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
Cardiac Devices·3,740 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HAN...
Medical Devices·1,380 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction ...
Medical Devices·400 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.
Medical Devices·500 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from metered dose inhaler...
Respiratory Devices·250 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. comp...
Medical Devices·8,150 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the direction of IV fluid flow.
Medical Devices·275 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
smiths medical portex Loss of Resistance Device, REF 100/398/000
Medical Devices·3,420 affected·Dec 8, 2020
High RiskFDA
Smiths Medical Asd Inc.
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Medical Devices·20 affected·May 26, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
Medical Devices·150 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
Medical Devices·20 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093
Medical Devices·13,620 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082
Medical Devices·870 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1
Medical Devices·17,980 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094
Medical Devices·3,620 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd Inc.
smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
Medical Devices·3,100 affected·Mar 10, 2020
High RiskFDA
Smiths Medical Asd, Inc.
Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
Medical Devices·127,700 affected·Jan 7, 2020
High RiskFDA
Smiths Medical Asd, Inc.
Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
Medical Devices·720,100 affected·Jan 7, 2020
High RiskFDA
Smiths Medical Asd Inc.
GRIPPER Needles sold individually. Labeled as the following item descriptions: 1. NDL, GRIPPER, 22G X 1" (25MM), 12/BX; 2. NDL...
Medical Devices·3,952,425 affected·Jul 8, 2019
High RiskFDA
Smiths Medical Asd Inc.
GRIPPER Needles sold as part of PORT-A-CATH II SINGLE LUMEN SYSTEM. Labeled as the following item descriptions: 1. TRAY, PAC, VEN, ...
Medical Devices·3,952,509 affected·Jul 8, 2019
High RiskFDA
Smiths Medical Asd Inc.
Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: ...
Medical Devices·7,840 affected·Feb 11, 2019
High RiskFDA
Smiths Medical Asd Inc.
Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use...
Medical Devices·109,000 affected·Feb 11, 2019
High RiskFDA
Smiths Medical Asd Inc.
Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000...
Medical Devices·20,884 affected·Oct 15, 2018
RecallFDA
Smiths Medical Asd Inc.
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name...
Medical Devices·29,600 affected·Jul 13, 2018
RecallFDA
Smiths Medical Asd Inc.
smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. P...
Respiratory Devices·3,000 affected·Jul 6, 2018
RecallFDA
Smiths Medical Asd Inc.
smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Prod...
Respiratory Devices·12,000 affected·Jul 6, 2018
RecallFDA
Smiths Medical Asd Inc.
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 21...
Respiratory Devices·850 affected·Jul 6, 2018
RecallFDA
Smiths Medical Asd Inc.
smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product ...
Respiratory Devices·2,550 affected·Jul 6, 2018
High RiskFDA
Smiths Medical Asd Inc.
Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Ele...
Medical Devices·28,578,939 affected·Jun 22, 2018
High RiskFDA
Smiths Medical Asd Inc.
Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-...
Medical Devices·28,578,939 affected·Jun 22, 2018
High RiskFDA
Smiths Medical Asd Inc.
medfusion Stopcock, 1-way and 4-way, Model Numbers (REF): a. 081-101BE b. 081-101GE c. 081-101GEE d. 081-101NE e. 081-102NE f. 081-...
Medical Devices·933,518 affected·May 10, 2018
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Infusion Pump, containing the Barrel Clamp Guide mechanism
Medical Devices·276 affected·Apr 13, 2018
High RiskFDA
Smiths Medical Asd Inc.
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Medical Devices·16 affected·Apr 2, 2018
High RiskFDA
Smiths Medical Asd Inc.
PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); b. DL, LP, PU, 2.2MM, WING-LOCK...
Medical Devices·1,077 affected·Dec 4, 2017
High RiskFDA
Smiths Medical Asd Inc.
BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 920654235, 920654335A, and 920674235A. (The differences in the r...
Medical Devices·10 affected·Nov 29, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Medical Devices·58 affected·Nov 22, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fl...
Medical Devices·16,600 affected·Nov 13, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump 3500 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fl...
Medical Devices·16,600 affected·Nov 13, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion Syringe Pump 4000 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fl...
Medical Devices·16,600 affected·Nov 13, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (exc...
Medical Devices·11,170,535 affected·Sep 25, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pembe...
Medical Devices·9,787 affected·Aug 22, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pem...
Medical Devices·9,787 affected·Aug 22, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manu...
Medical Devices·17,280 affected·Jun 5, 2017
High RiskFDA
Smiths Medical Asd Inc.
Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
Medical Devices·736,000 affected·Apr 4, 2017