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Smiths Medical ASD, Inc.

406 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 i recall (Z-0644-2014)Smiths Medical ASD, Inc.2014-01-08
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 i recall (Z-0645-2014)Smiths Medical ASD, Inc.2014-01-08
Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 i recall (Z-0646-2014)Smiths Medical ASD, Inc.2014-01-08
Medfusion 4000 Syringe Infusion Pumps Medfusion 4000 Syringe Infusion Pumps are designed f recall (Z-0540-2014)Smiths Medical ASD, Inc.2013-12-19
Portex Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25 The Regional Anesthe recall (Z-0156-2014)Smiths Medical ASD, Inc.2013-11-05
Portex Spinal Tray with Drugs 22g/25g Quincke; 15249-21 The Regional Anesthesia family of recall (Z-0157-2014)Smiths Medical ASD, Inc.2013-11-05
Portex Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia family of pr recall (Z-0158-2014)Smiths Medical ASD, Inc.2013-11-05
Portex Regional Anesthesia Tray with Drugs; 15548-20 The Regional Anesthesia family of pro recall (Z-0159-2014)Smiths Medical ASD, Inc.2013-11-05
Portex Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthesia family of pro recall (Z-0160-2014)Smiths Medical ASD, Inc.2013-11-05
Portex Spinal Tray with Drugs 25g Whitacre; 15597C-20 The Regional Anesthesia family of pr recall (Z-0161-2014)Smiths Medical ASD, Inc.2013-11-05
Portex Saddleblock Tray with Drugs 26g Quincke, 4745-20 The Regional Anesthesia family of recall (Z-0162-2014)Smiths Medical ASD, Inc.2013-11-05
Portex Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 The Regional recall (Z-0163-2014)Smiths Medical ASD, Inc.2013-11-05
Portex Saddleblock Tray with Drugs 25g Quincke; 4795-20 The Regional Anesthesia family of recall (Z-0164-2014)Smiths Medical ASD, Inc.2013-11-05
Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile recall (Z-2268-2013)Smiths Medical ASD, Inc.2013-09-23
Smiths Medical, Deltec: REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access Syst recall (Z-2269-2013)Smiths Medical ASD, Inc.2013-09-23
Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Co recall (Z-1239-2013)Smiths Medical ASD, Inc.2013-05-03
Wallace Sure-Pro Ultra Embryo Replacement Catheter with Obturator Product Code: PEB623 Sur recall (Z-1240-2013)Smiths Medical ASD, Inc.2013-05-03
Wallace Sure-Pro Ultra Embryo Replacement Catheter with Stylet Product Code:PES623 Sure-Pr recall (Z-1241-2013)Smiths Medical ASD, Inc.2013-05-03
Wallace Sure-Pro Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro Embr recall (Z-1242-2013)Smiths Medical ASD, Inc.2013-05-03
Wallace Sure-Pro Two Stage Embryo Replacement Catheter for difficult transfer with Stylet recall (Z-1243-2013)Smiths Medical ASD, Inc.2013-05-03
Wallace Sure-Pro Single Stage Embryo Replacement Catheter Product Code: PP623 Sure-Pro Emb recall (Z-1244-2013)Smiths Medical ASD, Inc.2013-05-03
Smiths Medical, BCI Remote Alarm Cable (Normally Open & Normally Closed), Reorder Numbers: recall (Z-1014-2013)Smiths Medical ASD, Inc.2013-03-29
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in criti recall (Z-0996-2013)Smiths Medical ASD, Inc.2013-03-26
Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, recall (Z-2107-2012)Smiths Medical ASD, Inc.2012-08-01
Smiths Medical HOTLINE 3 Blood and Fluid Warmer, Reorder Numbers: HL-390 Product Usage: Th recall (Z-1979-2012)Smiths Medical ASD, Inc.2012-07-09
Smiths Medical, Medfusion 3500 Syringe Pumps, Software version 5.0.0, Rx Only. These pumps recall (Z-1206-2012)Smiths Medical ASD, Inc.2012-03-14
Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange) recall (Z-0656-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona TTS Cuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange) recall (Z-0657-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 Product Usage: This tube is in recall (Z-0658-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Aire-Cuf Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 Product Usage: This tube is in recall (Z-0659-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped recall (Z-0660-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Neonatal Flex Tend Plus Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight recall (Z-0661-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5 - 5.5 (With recall (Z-0662-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Pediatric Flex Tend Plus Standard Tracheostomy Tube Sizes 2.5 - 5.5 (With recall (Z-0663-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 - 6.0 (W recall (Z-0664-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Pediatric Flex Tend Plus Extra Length Tracheostomy Tube Sizes 4.0 - 6.0 (W recall (Z-0665-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona TTS Cuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck Flange recall (Z-0666-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona TTS Cuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a Straight Neck Flange recall (Z-0667-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck Flange) recall (Z-0668-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a Straight Neck Flange) recall (Z-0669-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange) recall (Z-0670-2012)Smiths Medical ASD, Inc.2012-01-19
Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a Straight Neck Flange) P recall (Z-0671-2012)Smiths Medical ASD, Inc.2012-01-19
CADD High Volume Administration Set, REF 21-7081V-01, Sterile EO, Rx only, Made in Mexico, recall (Z-0775-2012)Smiths Medical ASD, Inc.2012-01-17
HOTLlNE Disposable Administration Sets, Product Codes L-70 Product Usage: Single patient u recall (Z-0422-2012)Smiths Medical ASD, Inc.2012-01-11
HOTLlNE Disposable Administration Sets, Product Codes L-70NI Product Usage: Single patient recall (Z-0423-2012)Smiths Medical ASD, Inc.2012-01-11
HOTLlNE Disposable Administration Sets, Product Code L-270 Product Usage: Single patient u recall (Z-0424-2012)Smiths Medical ASD, Inc.2012-01-11
HOTLlNE Disposable Administration Sets, Product Code L-370 Product Usage: Single patient u recall (Z-0425-2012)Smiths Medical ASD, Inc.2012-01-11
HOTLlNE Disposable Administration Sets, Product Code L-80 Product Usage: Single patient us recall (Z-0426-2012)Smiths Medical ASD, Inc.2012-01-11
Level 1 Normothermic I.V. Fluid Administration Sets, Product Code D-60HL , Product Usage: recall (Z-0427-2012)Smiths Medical ASD, Inc.2012-01-11
Level 1 Normothermic I.V. Fluid Administration Sets, Product Code DI-60HL , Product Usage: recall (Z-0428-2012)Smiths Medical ASD, Inc.2012-01-11
Smiths Medical, CADD-Solis ambulatory infusion pumps, Models 2100, REF 21-2101-0200-51 and recall (Z-0004-2012)Smiths Medical ASD, Inc.2011-10-04
Smiths Medical, CADD-Solis Ambulatory Infusion Pump, Model Number: 2100 and 2110, Reorder recall (Z-1033-2011)Smiths Medical ASD, Inc.2011-02-03
MEDFUSION SYRINGE INFUSION PUMP, MODELS 3010 AND 3010a WITH SOFTWARE VERSIONS 2.0.2, 2.0.3 recall (Z-2121-2010)Smiths Medical ASD, Inc.2010-08-02
CADD-LEGACY 1 Model 6400, Ambulatory Infusion Pump, REF 21-6400-51, Rx Only, Smiths Medica recall (Z-1235-2010)Smiths Medical ASD, Inc.2010-04-05
Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number 21-2145-01 only for recall (Z-1082-2010)Smiths Medical ASD, Inc.2010-03-11
Smiths Medical Medfusion model 3500 syringe Infusion pump, software version V3.0.6. Model recall (Z-0650-2010)Smiths Medical ASD, Inc.2010-01-15
Smiths Medical Medfusion model 3010a syringe Infusion pump. REF 3010A. Rx Only. Smiths Med recall (Z-0651-2010)Smiths Medical ASD, Inc.2010-01-15
Portex Continuous Epidural Tray, Reference 4037-20 An anesthesia conduction kit is a devic recall (Z-2050-2009)Smiths Medical ASD, Inc.2009-09-03
Medex MX821L 72 inch (182.9cm) Administration Sets, Standard Drip, Sterile Single Use, Lat recall (Z-1549-2008)Smiths Medical Asd Inc2008-07-30
Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end expiratory recall (Z-1379-2008)Smiths Medical ASD, Inc.2008-07-16
Smiths Medical Oxy-PEEP High Flow O2 with PEEP; Positive end expiratory pressure breathing recall (Z-1380-2008)Smiths Medical ASD, Inc.2008-07-16
Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4037, Smiths Medi recall (Z-0695-2008)Smiths Medical Asd Inc2008-01-31
Smiths Medical, Add-On Kids Kit , Blood Sampling System, Product Code: MX4033, Smiths Medi recall (Z-0696-2008)Smiths Medical Asd Inc2008-01-31
Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090 recall (Z-0100-2008)Smiths Medical ASD, Inc.2007-11-07
Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd recall (Z-0378-2007)Smiths Medical ASD, Inc.2007-01-25
Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd recall (Z-0339-2007)Smiths Medical ASD, Inc.2007-01-05
Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, lengt recall (Z-0260-2007)Smiths Medical ASD, Inc.2006-12-07
Level 1 Normothermic I.V. Fluid Administration Set REF D-60HL recall (Z-0250-2007)Smiths Medical ASD, Inc.2006-12-06
Level 1 Normothermic I.V. Fluid Administration Set REF DI-60HL (Foreign Distribution Only) recall (Z-0251-2007)Smiths Medical ASD, Inc.2006-12-06
Portex Continuous Epidural tray Ref 4948-17 recall (Z-0211-2007)Smiths Medical ASD, Inc.2006-11-22
Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 recall (Z-0046-2007)Smiths Medical ASD, Inc.2006-10-19
STS-400 Level1 Skin Temperature Sensor with 400 Series Thermistor recall (Z-0767-06)Smiths Medical ASD, Inc.2006-04-18
TTS-400J Level1 Tympanic Temperature Sensor with 400 Series Thermistor recall (Z-0768-06)Smiths Medical ASD, Inc.2006-04-18
Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080 recall (Z-0714-06)Smiths Medical ASD, Inc.2006-04-06
Bivona brand Mid-Range Aire-Cuf Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 6 recall (Z-0394-06)Smiths Medical ASD, Inc.2006-01-18
Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. recall (Z-0395-06)Smiths Medical ASD, Inc.2006-01-18
Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0 recall (Z-0396-06)Smiths Medical ASD, Inc.2006-01-18
Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, steril recall (Z-0338-06)Smiths Medical ASD, Inc.2006-01-06
Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67H recall (Z-0301-06)Smiths Medical ASD, Inc.2005-12-23
Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040. recall (Z-0302-06)Smiths Medical ASD, Inc.2005-12-23
4902 Glass L.O.R. Syringe recall (Z-0242-06)Smiths Medical ASD, Inc.2005-11-30
4903 Glass L.O.R. Syringe recall (Z-0243-06)Smiths Medical ASD, Inc.2005-11-30
4904 Glass L.O.R. Syringe recall (Z-0244-06)Smiths Medical ASD, Inc.2005-11-30
4950-16 Portex Epidural Mini-pack recall (Z-0245-06)Smiths Medical ASD, Inc.2005-11-30
4950-17 Portex Epidural Mini-pack recall (Z-0246-06)Smiths Medical ASD, Inc.2005-11-30
4950-18 Portex Epidural Mini-pack recall (Z-0247-06)Smiths Medical ASD, Inc.2005-11-30
4954-16 Portex Epidural Mini-pack recall (Z-0248-06)Smiths Medical ASD, Inc.2005-11-30
4954-17 Portex Epidural Mini-pack recall (Z-0249-06)Smiths Medical ASD, Inc.2005-11-30
A1272-17 Portex Epidural Mini-pack recall (Z-0250-06)Smiths Medical ASD, Inc.2005-11-30
A1378-18 Portex Epidural Mini-pack recall (Z-0251-06)Smiths Medical ASD, Inc.2005-11-30
A1967-18 Portex Epidural Mini-pack recall (Z-0252-06)Smiths Medical ASD, Inc.2005-11-30
A1991-18 Portex Epidural Mini-pack recall (Z-0253-06)Smiths Medical ASD, Inc.2005-11-30
A2549-22 Spinal Needle recall (Z-0254-06)Smiths Medical ASD, Inc.2005-11-30
A3176-18 Portex Epidural Mini-pack recall (Z-0255-06)Smiths Medical ASD, Inc.2005-11-30
Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obtur recall (Z-0930-05)Smiths Medical ASD, Inc.2005-06-25
Portex Per-Fit Percutaneous Dilational Tracheostomy Kit ,ID 7.0mm Product Number: 535070 recall (Z-0867-05)Smiths Medical ASD, Inc.2005-06-04
Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 8.0mm Product Number: 535080 recall (Z-0868-05)Smiths Medical ASD, Inc.2005-06-04
Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 9.0mm Product Number: 535090 recall (Z-0869-05)Smiths Medical ASD, Inc.2005-06-04
Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 7.0mm Product Number: 538070E recall (Z-0870-05)Smiths Medical ASD, Inc.2005-06-04
Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 8.0mm Product Number: 538080E recall (Z-0871-05)Smiths Medical ASD, Inc.2005-06-04
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