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Smiths Medical ASD, Inc.

406 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indic recall (Z-2421-2024)Smiths Medical ASD Inc.2024-08-03
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c recall (Z-1540-2024)Smiths Medical ASD Inc.2024-04-15
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000- recall (Z-1541-2024)Smiths Medical ASD Inc.2024-04-15
Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, recall (Z-1542-2024)Smiths Medical ASD Inc.2024-04-15
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716 recall (Z-1543-2024)Smiths Medical ASD Inc.2024-04-15
smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS recall (Z-1274-2024)Smiths Medical ASD Inc.2024-03-19
smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS recall (Z-1275-2024)Smiths Medical ASD Inc.2024-03-19
smiths medical Medfusion Model 3500 Syringe pump recall (Z-0863-2024)Smiths Medical ASD Inc.2024-02-01
smiths medical Medfusion Model 4000 syringe pump recall (Z-0864-2024)Smiths Medical ASD Inc.2024-02-01
Medex LOGICAL CATH LAB KIT, List Number M20754 recall (Z-0739-2024)Smiths Medical Asd Inc2024-01-17
1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRL recall (Z-0740-2024)Smiths Medical Asd Inc2024-01-17
6IN PRESSURE TUBING, List Number MX20617 recall (Z-0741-2024)Smiths Medical Asd Inc2024-01-17
Medex 700PSI STOPCOCK W/ROTATOR, List Number MX4331R recall (Z-0742-2024)Smiths Medical Asd Inc2024-01-17
HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP recall (Z-0743-2024)Smiths Medical Asd Inc2024-01-17
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP recall (Z-0744-2024)Smiths Medical Asd Inc2024-01-17
20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR recall (Z-0745-2024)Smiths Medical Asd Inc2024-01-17
Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R recall (Z-0746-2024)Smiths Medical Asd Inc2024-01-17
48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R recall (Z-0747-2024)Smiths Medical Asd Inc2024-01-17
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile. recall (Z-0205-2024)Smiths Medical ASD Inc.2023-10-31
Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electro recall (Z-0141-2024)Smiths Medical ASD Inc.2023-10-20
Medfusion Syringe Pump, Model 3500-500, v3, v4, v5, and v6 recall (Z-0076-2024)Smiths Medical ASD Inc.2023-10-06
Medfusion Syringe Pump, Model 3500VX-500, v3, v4, v5, and v6 recall (Z-0077-2024)Smiths Medical ASD Inc.2023-10-06
Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51 recall (Z-0078-2024)Smiths Medical ASD Inc.2023-10-06
Medfusion Syringe Pump, Model 4000-XXXX-XX: a) 0100-50, b) 0100-249, c) 0101-50, d) 0101-5 recall (Z-0079-2024)Smiths Medical ASD Inc.2023-10-06
Medfusion PLUNGER FLOAT PLATE, Component Number G6000069, used on infusion pump recall (Z-0080-2024)Smiths Medical ASD Inc.2023-10-06
Medfusion ASSEMBLY PLUNGER CASE LEFT 1/EA, Component Number G6001587, used on infusion pum recall (Z-0081-2024)Smiths Medical ASD Inc.2023-10-06
PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter recall (Z-2466-2023)Smiths Medical ASD Inc.2023-08-28
DuraLife Autoclavable Double Swivel Elbow, REF 60-0010 (UltraSet Product Code 66-1991); Sw recall (Z-1580-2023)Smiths Medical ASD Inc.2023-05-12
DuraLife Autoclavable Silicone Extension Tube, REF 60-1502 (UltraSet Product Code 66-2509) recall (Z-1581-2023)Smiths Medical ASD Inc.2023-05-12
DuraLife Autoclavable Silicone Extension Tube, REF 60-1510 (UltraSet Product Code 66-2505) recall (Z-1582-2023)Smiths Medical ASD Inc.2023-05-12
CADD Administration Set, List Numbers: a) REF 21-7346-24; b) REF 21-7363-24 recall (Z-0962-2023)Smiths Medical ASD Inc.2023-01-30
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24 3) REF 21-7302 recall (Z-0963-2023)Smiths Medical ASD Inc.2023-01-30
CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-731 recall (Z-0964-2023)Smiths Medical ASD Inc.2023-01-30
CADD Administration Set, List Numbers: a) REF 21-7600-24, b) REF 21-7609-24, c) REF 21-762 recall (Z-0965-2023)Smiths Medical ASD Inc.2023-01-30
CADD Administration Set, List Numbers: 1) REF 21-7300-24, 2) REF 21-7301-24, 3) REF 21-730 recall (Z-0966-2023)Smiths Medical ASD Inc.2023-01-30
Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that h recall (Z-0272-2023)Smiths Medical ASD Inc.2022-11-21
Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe recall (Z-0653-2022)Smiths Medical ASD Inc.2022-02-17
CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-010 recall (Z-0107-2022)Smiths Medical ASD Inc.2021-10-19
JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13 recall (Z-1798-2021)Smiths Medical ASD Inc.2021-06-10
LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sa recall (Z-1470-2021)Smiths Medical ASD Inc.2021-04-21
Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling recall (Z-1471-2021)Smiths Medical ASD Inc.2021-04-21
Left Heart Kit, Model Number M20268. for blood pressure monitoring. recall (Z-1472-2021)Smiths Medical ASD Inc.2021-04-21
LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring. recall (Z-1473-2021)Smiths Medical ASD Inc.2021-04-21
Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks an recall (Z-1474-2021)Smiths Medical ASD Inc.2021-04-21
ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and recall (Z-1475-2021)Smiths Medical ASD Inc.2021-04-21
Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1 recall (Z-1476-2021)Smiths Medical ASD Inc.2021-04-21
Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR recall (Z-1477-2021)Smiths Medical ASD Inc.2021-04-21
HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are recall (Z-1478-2021)Smiths Medical ASD Inc.2021-04-21
HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEM recall (Z-1479-2021)Smiths Medical ASD Inc.2021-04-21
Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. recall (Z-1480-2021)Smiths Medical ASD Inc.2021-04-21
Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascu recall (Z-1481-2021)Smiths Medical ASD Inc.2021-04-21
Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1 recall (Z-2734-2020)Smiths Medical ASD Inc.2020-08-06
Medfusion Syringe Pump Model 3500, Software Version V6.0. Infusion pump. recall (Z-2735-2020)Smiths Medical ASD Inc.2020-08-06
Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Ele recall (Z-1715-2020)Smiths Medical ASD, Inc.2020-04-15
Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrol recall (Z-1716-2020)Smiths Medical ASD, Inc.2020-04-15
Medfusion Syringe Pump, Model 4000. The Model 4000 pump is a small, lightweight and portab recall (Z-0610-2020)Smiths Medical ASD Inc.2019-12-12
PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1 recall (Z-1073-2018)Smiths Medical ASD Inc.2018-03-15
Power PORT-A-CATH II, TRAY POWER PAC II. Labeled as: a. VEN, PU, 2.6MM, UL 8.5 FR/INTRO, V recall (Z-1074-2018)Smiths Medical ASD Inc.2018-03-15
Medfusion Syringe Pump 4000 Series The Medfusion Syringe Infusion Pumps are indicated for recall (Z-1134-2018)Smiths Medical ASD Inc.2018-03-05
Medfusion Syringe Pump 3500 Series The Medfusion Syringe Infusion Pumps are indicated for recall (Z-1135-2018)Smiths Medical ASD Inc.2018-03-05
Medfusion Syringe Pump 3010 Series The Medfusion Syringe Infusion Pumps are indicated for recall (Z-1136-2018)Smiths Medical ASD Inc.2018-03-05
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smith recall (Z-0307-2018)Smiths Medical ASD Inc.2018-01-02
CADD Administration Set, 21-7339-24, Rx Only, Sterile EO. recall (Z-1767-2017)Smiths Medical ASD Inc.2017-03-30
NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-I recall (Z-1105-2017)Smiths Medical ASD, Inc.2017-01-26
Acuvance2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance 2 Safety Cathet recall (Z-0789-2017)Smiths Medical ASD Inc.2016-12-19
PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 Th recall (Z-0152-2016)Smiths Medical ASD, Inc.2015-10-21
CADD- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Vers recall (Z-1813-2015)Smiths Medical ASD, Inc.2015-06-18
Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGE recall (Z-1730-2015)Smiths Medical Asd Inc2015-06-08
Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A. recall (Z-1692-2015)Smiths Medical ASD, Inc.2015-05-29
CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx onl recall (Z-1286-2015)Smiths Medical ASD, Inc.2015-03-17
Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gase recall (Z-1028-2015)Smiths Medical ASD, Inc.2015-01-29
Hypodermic Needle Pro Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: Th recall (Z-0897-2015)Smiths Medical ASD, Inc.2014-12-30
Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reor recall (Z-0898-2015)Smiths Medical ASD, Inc.2014-12-30
Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reord recall (Z-0899-2015)Smiths Medical ASD, Inc.2014-12-30
CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. recall (Z-0166-2015)Smiths Medical ASD, Inc.2014-11-01
4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Int recall (Z-2536-2014)Smiths Medical ASD, Inc.2014-08-28
H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal recall (Z-2537-2014)Smiths Medical ASD, Inc.2014-08-28
H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal In recall (Z-2538-2014)Smiths Medical ASD, Inc.2014-08-28
H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal recall (Z-2539-2014)Smiths Medical ASD, Inc.2014-08-28
H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit recall (Z-2540-2014)Smiths Medical ASD, Inc.2014-08-28
H4052 Endo Tube Holder, Pedi 3.0mm Pediatric Endotracheal Intubation Kit recall (Z-2541-2014)Smiths Medical ASD, Inc.2014-08-28
Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used recall (Z-1641-2014)Smiths Medical ASD, Inc.2014-06-11
SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Con recall (Z-1650-2014)Smiths Medical ASD, Inc.2014-05-22
Smiths Medical HOTLINE Fluid Warming Set L-70. Product Usage: intended for the delivery of recall (Z-1443-2014)Smiths Medical ASD, Inc.2014-04-09
Smiths Medical HOTLINE Fluid Warming Set L-80. Product Usage: intended for the delivery of recall (Z-1444-2014)Smiths Medical ASD, Inc.2014-04-09
4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per recall (Z-1180-2014)Smiths Medical ASD, Inc.2014-03-12
4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with F recall (Z-1181-2014)Smiths Medical ASD, Inc.2014-03-12
4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with F recall (Z-1182-2014)Smiths Medical ASD, Inc.2014-03-12
4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with recall (Z-1183-2014)Smiths Medical ASD, Inc.2014-03-12
4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with recall (Z-1184-2014)Smiths Medical ASD, Inc.2014-03-12
4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filte recall (Z-1185-2014)Smiths Medical ASD, Inc.2014-03-12
4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Fi recall (Z-1186-2014)Smiths Medical ASD, Inc.2014-03-12
4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Fi recall (Z-1187-2014)Smiths Medical ASD, Inc.2014-03-12
G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with F recall (Z-1188-2014)Smiths Medical ASD, Inc.2014-03-12
G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Fi recall (Z-1189-2014)Smiths Medical ASD, Inc.2014-03-12
G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Fi recall (Z-1190-2014)Smiths Medical ASD, Inc.2014-03-12
G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. recall (Z-1191-2014)Smiths Medical ASD, Inc.2014-03-12
G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Fi recall (Z-1192-2014)Smiths Medical ASD, Inc.2014-03-12
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 i recall (Z-0642-2014)Smiths Medical ASD, Inc.2014-01-08
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 i recall (Z-0643-2014)Smiths Medical ASD, Inc.2014-01-08
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