642 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
FDA Recall
Terminated
·Sterilmed Inc·Product code DYB·June 2, 2017
St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheaths are indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
FDA Enforcement
Class I
·Terminated·Sterilmed Inc·January 3, 2018
Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
FDA Recall
Terminated
·Circulatory Technology Inc·Product code DTN·March 3, 2016
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
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
CES Ultra, Cranial Electrotherapy Stimulator, Serial Numbers: 1000 through 3999, Manufactured by Arco Electronics Limited, Distributed by Neuro-Fitness LLC, Fall City, Washington 98024
FDA Recall
Terminated
·Neuro-Fitness LLC·Product code JXK·October 29, 2007
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
ARC DISASTER KIT (American Red Cross), Part Number 7201, UPC 0-91966-04708-6, The kit is labeled in parts: "***American Red Cross***Item 7201*** 2 IODINE PREP PADS***Produced by the American Red Cross***Oregon Trail Chapter***503-528-5848***PO Box 3200, Portland, OR 97208***www.RedCross.org***". First aid kit.
FDA Recall
Terminated
·Lifeline First Aid LLC·Product code LRR·July 7, 2011
First Aid Only brand cabinets (typically metal wall mount) containing ibuprofen tablets and a variety of other first aid supplies: Item 249-0/FAO Item 249-0/P Item 249-RK/P First Aid Exchange brand cabinet: Item 1300-FAE-0103 Item 1300-FAE-0108 and Item 1300-PAT-0109
FDA Recall
Terminated
·First Aid Only Inc·Product code LRR·December 10, 2007
Base Camp First Aid Kit, Part Number 4150, UPC 0-91966-04150-3, contains 171 pieces. The kit is labeled in parts: "***BASE CAMP FIRST AID KIT***171 PIECE*** 6 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