1,557 results
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Sources: EU EUDAMED, US FDA
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Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A Labeled in part: ONE SET - SINGLE USE CATALOG NO. 8002A PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42'' 1-PRESSURE GAGE LINE 1-PATIENT HOSE 22mmIDx6'' 1-EXHALATION VALVE w/HOLDING ARM& COLLECTION HEAD 48'' w/CUFF 1/4''ID 1-ADULT PRESSURE TEE w/CUFF 1-EXHALATION VALVE LINE 1/8''IDx48'' 2-ADAPTERS 22mmx22mm
FDA Recall
Terminated
·Bio-Med Devices, Inc.·Product code CBK·December 6, 2004
Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-7 Labeled in part: ONE SET - SINGLE USE ATALOG NO. 8002A-7 PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx60'' 1-EXHALATION VALVE LINE 1/8''IDx90'' 1-PATIENT HOSE 22mmIDx18'' 1-PATIENT HOSE 22mmIDx6'' 1-PRESSURE GAGE LINE 84'' w/CUFF 1/4''ID 1-EXHALATION VALVE w/HOLDING ARM& COLLECTION HEAD 1-ADULT PRESSURE TEE w/CUFF 3-ADAPTERS 22mmx22mm
FDA Recall
Terminated
·Bio-Med Devices, Inc.·Product code CBK·December 6, 2004
Bio Med Devices Patient Breathing Circuit Catalog Number: 80011 Labeled in part: '':PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42'' 1-PRESSURE GAGE LINE 3/16''IDx54'' 1-PATIENT HOSE 22mmIDx24'' 3-ADAPTERS 22mm x 22mm 1-PATIENT HOSE 22mmIDx6'' 1-ADULT PRESSURE TEE 1-EXHALATION VALVE w/HOLDING ARM& 1-TEMPERATURE ADAPTER 22mmID x 22mm COLLECTION HEAD 2-CUFF 1/4''ID x 5/4'' 1-EXHALATION VALVE LINE 1/8''IDx52''
FDA Recall
Terminated
·Bio-Med Devices, Inc.·Product code CBK·December 6, 2004
Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-9 Labeled in part: ONE SET - SINGLE USE CATALOG NO. 8002A-9 PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx60'' 1-EXHALATION VALVE LINE 1/8''IDx108'' 1-PATIENT HOSE 22mmIDx36'' 1-PATIENT HOSE 22mmIDx6'' 1-PRESSURE GAGE LINE 1-EXHALATION VALVE w/HOLDING ARM&COLLECTION HEAD 102'' w/CUFF 1/4''ID 1-ADULT PRESSURE TEE w/CUFF 3-ADAPTERS 22mmx22mm
FDA Recall
Terminated
·Bio-Med Devices, Inc.·Product code CBK·December 6, 2004
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
FDA Recall
Terminated
·Circulatory Technology Inc·Product code DTN·March 3, 2016
The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
FDA Recall
Terminated
·Circulatory Technology Inc·Product code DTN·July 1, 2016
5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.
FDA Enforcement
Class II
·Terminated·Lifeline First Aid LLC·July 13, 2016
Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline. UPC Red color kit: 845174005464; UPC Lime color kit: 845174005594; UPC Purple color: 845174005600; UPC of master case of 6 845174005471 (2 each color) Item # 4037, Outfitter First Aid Kit, CPR shield with one way valve & barrier filter, brand Lifeline, UPC 845174003453
FDA Enforcement
Class II
·Terminated·Lifeline First Aid LLC·July 13, 2016
Liposuction Pack FJG, code 900-3115, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMIIII LIF (2) TOWEL ABSORBENT 15" X 20" LIF (1) NEEDLE HYPODERMIC 25 X 1 LIF (1) BOWL UTILITY QUART 32oz LIF (1) COVER MAYO STAND REINFORCED L/F (20) GAUZE SPONGE 4" X 4" 16PLY LIF (1) COVER TABLE REINFORCED 44" X 78" LIF (2) CUP DENTURE 8oz TEAL WITH LID LIF (6) TOWEL CLOTH HUCK BLUE LIF (1) SAFETY SCALPEL #15 DISPOSABLE LIF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE L/F (1) SHEET% DRAPE REINFORCED 60" X 77" LIF (1) PR. GLOVE SURG. CUSTOMGUARD CHLOROPRENE #7 P/F L/F (2) PR. GLOVE SURG CUSTOMGUARD CHLOROPRENE #6.5 P/F L/F (1) DRAPE TOP WITH ADHESIVE 108" X 50" STD SMS L/F (1) DRAPE BOTTOM ABS REINF. 71" X 62" STD SMS WITH TAPE L/F (2) DRAPE SIDE 42" X 76" WITH TAPE LIF (1) PVP IODOPHOR BOTTLE 4oz PAINT (1) SUCTION TUBING 8' X 3/8" ID NON CONDUCTIVE LIF (1) STRIP STERI CLOSURE Y2" X 4" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code LRO·May 20, 2014
External Drainage Sets labeled NMT NeuroSciences Implants or Integra NeuroSciences Implants, S.A.
FDA Recall
Terminated
·Integra LifeSciences Corp·Product code LID·December 16, 2002
VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog number 1721869 and packaged as 90 slides/pack catalog number 1726926 VITROS AMON Slides quantitatively measure ammonia concentration in plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JID·June 12, 2013
NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge cannula to aid in the delivery of chemicals. The NanoTip base is made from a polypropylene copolymer. The stainless steel cannula is made from 304 SS, and is 30-gauge in diameter and 0.488 in length. The cannula is secured in the base with an epoxy adhesive. Indications: Tips, when used in conjunction with the range of available syringes and products, provide a technique that is designed to provide a faster, easier, and more precise delivery. They are designed and created in such a way to generate less product waste and provide optimum control/leverage. Tips are also used for moisture removal and for directing laser light beam. Each of the tips is part of delivery systems designed for dentist-supervised, intra-oral procedures. The NanoTIp is designed for use with dental products manufactured by Ultradent Products, Inc. such as: UltraSeal XT plus, UltraSeal XT hydro, Ultra-Etch, PermaFloIdeal for microscopic restorative dentistry
FDA Recall
Terminated
·Ultradent Products, Inc.·Product code EID·December 14, 2016
B12 Reagent (6C09-20 and 6C09-25) for use with the ARCHITECT i2000 and i2000SR Analyzers, List numbers 8C89-01 and 3M74-01. The reagent is manufactured by Abbott Laboratories, Abbott Park, IL. The ARCHITECT instrument is manufactured by Abbott Laboratories, Irving Texas
FDA Recall
Terminated
·Abbott Laboratories, Inc·Product code LID·December 14, 2001
Highlands First Aid Kit, Part Number 4116, UPC 0-91966-04116-9, contains 65 Pieces. The kit is labeled in parts: "***HIGHLANDS FIRST AID KIT***MODEL 4166*** 1 IODINE PREP PADS***Lifeline First Aid, LLC***Wilsonville, OR 97070, USA***www.lifelinefirstaid.com***". First aid kit.
FDA Recall
Terminated
·Lifeline First Aid LLC·Product code LRR·July 7, 2011
Item # 4042-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline, UPC 845174004429 each; UPC 845174004436 master case of 6. Item #4043-CPR Rescue Kit, containing CPR shield with one way valve & barrier filter. brand Lifeline. UPC Red color kit: 845174005464; UPC Lime color kit: 845174005594; UPC Purple color: 845174005600; UPC of master case of 6 845174005471 (2 each color) Item # 4037, Outfitter First Aid Kit, CPR shield with one way valve & barrier filter, brand Lifeline, UPC 845174003453
FDA Recall
Terminated
·Lifeline First Aid LLC·Product code CBP·May 16, 2016
First Aid kits, First Aid Only brand, containing various products to include acetaminophen and other first aid supplies, various sizes, - travel size, all purpose, first aid response kit, on-the-road, recreational, outdoor. First Aid Only, Inc. Vancouver, WA
FDA Recall
Terminated
·First Aid Only Inc·Product code LRR·August 17, 2006
First Aid kits, Pharmacist''s Choice, containing acetaminophen and a variety of first aid items, all purpose first aid kit.
FDA Recall
Terminated
·First Aid Only Inc·Product code LRR·August 17, 2006
Wilderness First Aid Kit, Part Number 4120; UPC 0-91966-04120-6, contains 110 Pieces. The kit is labeled in parts: "***WILDERNESS FIRST AID KIT***MODEL 4120*** 2 IODINE PREP PADS***Lifeline First Aid, LLC***Wilsonville, OR 97070, USA***www.lifelinefirstaid.com***". First aid kit.
FDA Recall
Terminated
·Lifeline First Aid LLC·Product code LRR·July 7, 2011
5195GM, Cadillac First Aid Kit, #23459698, brand General Motors. No UPC.
FDA Recall
Terminated
·Lifeline First Aid LLC·Product code CBP·May 16, 2016
Ibuprofen tablet refills in cardboard boxes or clear plastic bags for first aid kits and cabinets First Aid Only, Inc., Vancouver, WA. Ibuprofen Tablets, Item A405-WIP, Item A405-10 Ibuprofen Tablets, Item FAE-7014;; Ibuprofen Tablets, Item H430; Ibuprofen Tablets, Item I431; Ibuprofen Tablets, item J432 and Ibuprofen Tablets, item Z6100
FDA Recall
Terminated
·First Aid Only Inc·Product code GAA41·December 10, 2007