360 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Nitrate Reagent A, Cat No. Z71, Lot 3338 Nitrate Reagent B, Cat No. A72, Lot 3338
FDA Recall
Terminated
·Hardy Media Inc Dba Hardy Diag·Product code JTO·December 31, 2003
NOW Malaria (Export use only) Item Number 660-430, Kit Number 66005, Kit Number 660-000
FDA Recall
Terminated
·Binax, Inc.·Product code NED·February 18, 2004
Codman External Drainage System 3 (EDS 3) CSF Without Ventricular Catheter Catalog Number: 82-1731
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·August 4, 2006
ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and collection from peripheral arterial line catheters.
FDA Enforcement
Class I
·Terminated·Hummingbird Med·July 13, 2016
ABG-HM-1 Hummi Micro Draw Blood Transfer Device Product Usage: It is used for blood transfer and collection from Peripheral Arterial Line Catheters.
FDA Enforcement
Class I
·Terminated·Hummingbird Med·June 1, 2016
ON-Q PainBuster with OnDemand (270 ml, 2 ml/hr + 5 ml bolus /60 min refill), Model PMB01, I-Flow Corporation, Lake Forest, CA 92630 U.S.A.
FDA Recall
Terminated
·I-Flow Corporation·Product code MED·March 27, 2007
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
FDA Recall
Terminated
·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011
product labeled in part: ''***banicide ADVANCED, A Reusable Sterilizing & Disinfecting Solution***Active Ingredient: Glutaraldehyde (1,5 Pentanedial) 3.5%***NET CONTENTS: 3.8l (ONE U.S. GALLON)***Manufactured by Pascal Company, Inc. 2929 N.E. Northup Way P.O. Box 1478 Bellevue, WA 98009-1478 USA***''
FDA Recall
Terminated
·Pascal Co Inc·Product code MED·August 9, 2005
QPC1680 Quick Connect, for Pentax 30/40/K Series Two-Channel GI Endoscopes, in the Steris System 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray, Cat No. QPT1680
FDA Recall
Terminated
·Steris Corp·Product code MED·March 15, 2004
CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.
FDA Recall
Terminated
·Advanced Sterilization Products·Product code MED·June 1, 2012
Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for sterilization of flexible endoscopes.
FDA Recall
Terminated
·Steris Corp·Product code MED·February 19, 2008
Steris QFC1728 and QFC1729 Quick Connects;(used to connect gastrointestinal endoscopes to processing trays) The malfunctioning piece of the quick connect component is adaptor #6, STERIS part number 201158. Adaptor #6 attaches to the suction port of the endoscope.
FDA Recall
Terminated
·Steris Corporation Hopkins Facility·Product code MED·September 12, 2007
STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System The SYSTEM 1 E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned impressible, reusable, critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. Devices processed in a SYSTEM IE have been chemically sterilized using S40 Sterilant Concentrate, a peracetic acid liquid chemical sterilant and rinsed with extensively treated, potable water.
FDA Recall
Terminated
·Steris Corporation Hopkins Facility·Product code MED·March 14, 2011
QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
FDA Recall
Terminated
·Steris Corporation·Product code MED·August 10, 2012
Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing, tethers and adapters for connecting specified devices to Flexible Processing Trays/Containers.
FDA Recall
Terminated
·Steris Corporation·Product code MED·March 4, 2013
The product is a sheath meant to fit over a Nasopharyngoscope and is labeled as EndoScrub 2 Sheaths
FDA Recall
Terminated
·Medtronic Xomed, Inc.·Product code FED·January 29, 2004
Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to maintain and maximize the viewable mucosa during endocosopic therapy by manipulating colonic folds
FDA Recall
Terminated
·Boddingtons Plastics Ltd Wheelbarrow Park Estate Pattenden Lane Tonbridge United Kingdom·Product code FED·March 11, 2020
Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog No 250-228, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FED·November 5, 2013
Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FED·November 5, 2013
The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
FDA Recall
Terminated
·Steris Corporation·Product code MED·August 1, 2012