107 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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ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.
FDA Recall
Terminated
·Abbott Laboratories·Product code NIG·May 30, 2012
ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA-19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.
FDA Enforcement
Class II
·Terminated·Abbott Laboratories·July 4, 2012
Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use device inserted into the patient's trachea via the mouth to maintain an open airway; Hudson RCI, Temecula, CA 92589-9020, Manufactured in Mexico, Catalog number (REF) V5-10316 (8.0 mm)
FDA Recall
Terminated
·Teleflex Medical·Product code BTR·January 14, 2005
Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, Model number 85863,shipped in cases of 20
FDA Recall
Terminated
·Nellcor Puritan Bennett·Product code BSR·July 12, 2006
Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 2.5 mm Product Code: 100/141/025. Intended for oral and/or nasal intubation for airway management.
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009
Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Siliconized, 3.5 mm Product Code: 100/141/035. Intended for oral and/or nasal intubation for airway management.
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009
Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc, Englewood, CO 80112. Contains one lighted stylet per pack.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·August 11, 2008
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
FDA Recall
Terminated
·Teleflex Medical·Product code BTR·January 6, 2014
Rsch Flexi-Slip Endotracheal Tube Stylet with Soft Distal Tip, Sterile, Rx only, Teleflex Medical.
FDA Recall
Terminated
·Teleflex Medical·Product code BSR·August 24, 2015
Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
FDA Recall
Terminated
·Teleflex Medical·Product code BTR·May 24, 2019
Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0 mm, Product Code 5-10316 6) HVT 8.5 mm, Product Code 5-10317 Product Usage: Tracheal tube/airway management
FDA Recall
Terminated
·Teleflex Medical·Product code BTR·May 24, 2019
Portex Polar Preformed Tracheal Tube, South Oral, Murphy Eye, Clear 3.5 mm Product Code: 100/134/035. Intended for oral and/or nasal intubation for airway management.
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009
Portex Tracheal Tube, Cut to Length, Oral, Siliconized, 2.5 mm Product Code: 100/126/025. Intended for oral and/or nasal intubation for airway management.
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009
Portex Uncuffed Paediatric Sized Tracheal Tube Oral Nasal, Ivory 3.0 mm, Product Code: 100/105/030. Intended for oral and/or nasal intubation for airway management.
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009
Portex Tracheal Tube, Oral/Nasal, Murphy Eye, Clear, 3.0 mm Product Code: 100/127/030. Intended for oral and/or nasal intubation for airway management.
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BTR·August 25, 2009
Kimberly Clark Microcuff Endotracheal Tube, Pediatric Oral Curved, sizes 3.0mm, 3.5mm, 4.0mm and 4.5mm, Rx Only, Sterile, Manufacturer: Kimberly-Clark NV Belgicastraat 13, 1930 Zaventem, Belgium, Made in Malaysia
FDA Recall
Terminated
·Kimberly-Clark Corporation·Product code BTR·June 4, 2007
Light Wand Intro Pack, Part Number: 3960, Sterile, Vital Signs Colorado, Inc., Englewood, CO. Contains 5 lighted stylets per pack.
FDA Recall
Terminated
·Vital Signs Colorado Inc.·Product code BSR·August 11, 2008
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
FDA Recall
Terminated
·Teleflex Medical·Product code BTR·January 6, 2014
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
FDA Recall
Terminated
·Teleflex Medical·Product code BTR·January 6, 2014
Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Tracheal tube/airway management
FDA Recall
Terminated
·Teleflex Medical·Product code BTR·July 30, 2019