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Recall Observatory FDA recall evidence

Core noun

Device recall evidence

Joined enrichment rows that support device recall linkage and root-cause wording.

Indexed record set

39,516 evidence rows

Page 1523 of 1581

Evidence Product Join Root cause
device-recall:cfres:166056 Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. Official recall number · Z-2784-2018 Employee error
device-recall:cfres:166009 Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period. Official recall number · Z-2759-2018 Employee error
device-recall:cfres:167020 Bronchofiberscope BF-XP60 Official recall number · Z-3307-2018 Other
device-recall:cfres:165134 Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542 Official recall number · Z-3251-2018 Under Investigation by firm
device-recall:cfres:167284 Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety of procedures. Official recall number · Z-3278-2018 Nonconforming Material/Component
device-recall:cfres:167016 Ultrasonic Bronchoscope BF-UC160F-OL8 Official recall number · Z-3303-2018 Other
device-recall:cfres:167001 Bronchovideoscope F-1TQ180 Official recall number · Z-3288-2018 Other
device-recall:cfres:165492 VITROS Sodium Slides, Catalog # 837 9034 Official recall number · Z-3280-2018 Nonconforming Material/Component
device-recall:cfres:167015 Bronchovideoscope BF-Q180-AC Official recall number · Z-3302-2018 Other
device-recall:cfres:167203 ACCOLADE Pacemaker Official recall number · Z-3257-2018 Component design/selection
device-recall:cfres:167005 Bronchofiberscope BF-40 Official recall number · Z-3292-2018 Other
device-recall:cfres:166537 VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use. Official recall number · Z-3009-2018 Under Investigation by firm
device-recall:cfres:166293 Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 380 mm, Item Number: 814311380 Official recall number · Z-3061-2018 Under Investigation by firm
device-recall:cfres:166385 Affixus¿ Hip Fracture Nail 130¿ 13 mm x 180 mm, Item Number: 814513180 Official recall number · Z-3132-2018 Under Investigation by firm
device-recall:cfres:166341 Affixus¿ Hip Fracture Nail 130¿ 9 mm x 180 mm, Item Number: 814509180 Official recall number · Z-3108-2018 Under Investigation by firm
device-recall:cfres:166386 Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 260 mm, Item Number: 814513260 Official recall number · Z-3133-2018 Under Investigation by firm
device-recall:cfres:166181 VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma and urine using VITROS 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. Product Usage: Official recall number · Z-3044-2018 Under Investigation by firm
device-recall:cfres:166314 Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 320 mm, Item Number: 814409320 Official recall number · Z-3081-2018 Under Investigation by firm
device-recall:cfres:166426 Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 420 mm, Item Number: 814613420 Official recall number · Z-3171-2018 Under Investigation by firm
device-recall:cfres:166820 IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of all pressure injuries (including stages 1,2,3,4, unstageable injury, and deep tissue injury) and is recommended to be implemented in combination with clinical evaluation of risk factors and skin assessments made by a health care professional. This support surface is for use with human patients with existing or at risk of incurring pressure injuries. The patient must not exceed the safe working load as specified by the support surface. A healthcare professional should determine the use of this support surface by patients outside of the therapeutic weight range. The minimum patient age requirement for this support surface is two years. IsoFlex LAL shall be used with a support surface cover at all times. The support surface cover can interact with all external skin. This support surface is for use by patients in an acute care setting. This may include critical care, step down, progressive care, med/surg, subacute care, and post anesthesia care unit (PACU), or other locations as prescribed by a physician. Operators of this support surface include healthcare professionals (such as nurses, nurse aids, or doctors). IsoFlex LAL support surface is not intended to: be used in a home health environment setting be used as a sterile product include a measuring function be used with a patient less than two years of age Stryker promotes the clinical assessment of each patient and appropriate usage by the operator. Official recall number · Z-3181-2018 Mixed-up of materials/components
device-recall:cfres:165305 Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized. Official recall number · Z-3028-2018 Labeling False and Misleading
device-recall:cfres:166414 Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 440 mm, Item Number: 814611440 Official recall number · Z-3161-2018 Under Investigation by firm
device-recall:cfres:166536 VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use. Official recall number · Z-3008-2018 Under Investigation by firm
device-recall:cfres:166424 Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 380 mm, Item Number: 814613380 Official recall number · Z-3169-2018 Under Investigation by firm
device-recall:cfres:166602 CE18TKCD CONT EPIDURAL TRAY, Material Number 332211 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids. Official recall number · Z-3356-2018 Under Investigation by firm

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