Core noun
Device recall evidence
Joined enrichment rows that support device recall linkage and root-cause wording.
Indexed record set
39,516 evidence rows
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- Evidence
- device-recall:cfres:165452
- Product
- 120" (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of blood.
- Join
- Official recall number ·
Z-2627-2018 - Root cause
- Labeling mix-ups
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- Evidence
- device-recall:cfres:166073
- Product
- 1mL Medallion Syringes Are used to inject fluids into, or withdraw fluids from the body.
- Join
- Official recall number ·
Z-2742-2018 - Root cause
- Nonconforming Material/Component
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- Evidence
- device-recall:cfres:162017
- Product
- radial stem implant #1 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
- Join
- Official recall number ·
Z-2725-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:162012
- Product
- #4 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
- Join
- Official recall number ·
Z-2720-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166537
- Product
- VENTANA Basal Cell Cktl, (34BE12+p63)250, Catalog Number 06419445001, Model 790-1010 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Join
- Official recall number ·
Z-3009-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166539
- Product
- CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Join
- Official recall number ·
Z-3011-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166385
- Product
- Affixus¿ Hip Fracture Nail 130¿ 13 mm x 180 mm, Item Number: 814513180
- Join
- Official recall number ·
Z-3132-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166293
- Product
- Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 380 mm, Item Number: 814311380
- Join
- Official recall number ·
Z-3061-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166341
- Product
- Affixus¿ Hip Fracture Nail 130¿ 9 mm x 180 mm, Item Number: 814509180
- Join
- Official recall number ·
Z-3108-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166386
- Product
- Affixus¿ Hip Fracture Nail Right 130¿ 13 mm x 260 mm, Item Number: 814513260
- Join
- Official recall number ·
Z-3133-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166181
- Product
- 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:
- Join
- Official recall number ·
Z-3044-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166314
- Product
- Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 320 mm, Item Number: 814409320
- Join
- Official recall number ·
Z-3081-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166426
- Product
- Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 420 mm, Item Number: 814613420
- Join
- Official recall number ·
Z-3171-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166820
- Product
- 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.
- Join
- Official recall number ·
Z-3181-2018 - Root cause
- Mixed-up of materials/components
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- Evidence
- device-recall:cfres:165305
- Product
- Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
- Join
- Official recall number ·
Z-3028-2018 - Root cause
- Labeling False and Misleading
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- Evidence
- device-recall:cfres:166290
- Product
- Affixus¿ Hip Fracture Nail Right 125¿ 11 mm x 320 mm, Item Number: 814311320
- Join
- Official recall number ·
Z-3058-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166414
- Product
- Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 440 mm, Item Number: 814611440
- Join
- Official recall number ·
Z-3161-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166536
- Product
- VENTANA ISH iView Blue Detection Kit, Catalog Number 05278511001, model 800-092 Immunohistochemistry (IHC) for in vitro diagnostic use.
- Join
- Official recall number ·
Z-3008-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166421
- Product
- Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 320 mm, Item Number: 814613320
- Join
- Official recall number ·
Z-3166-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166303
- Product
- Affixus¿ Hip Fracture Nail Right 125¿ 13 mm x 340 mm, Item Number: 814313340
- Join
- Official recall number ·
Z-3071-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166402
- Product
- Affixus¿ Hip Fracture Nail Left 130¿ 9 mm x 360 mm, Item Number: 814609360
- Join
- Official recall number ·
Z-3149-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166287
- Product
- Affixus¿ Hip Fracture Nail 125¿ 11 mm x 180 mm, Item Number: 814311180
- Join
- Official recall number ·
Z-3055-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166316
- Product
- Affixus¿ Hip Fracture Nail Left 125¿ 9 mm x 360 mm, Item Number: 814409360
- Join
- Official recall number ·
Z-3083-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:166424
- Product
- Affixus¿ Hip Fracture Nail Left 130¿ 13 mm x 380 mm, Item Number: 814613380
- Join
- Official recall number ·
Z-3169-2018 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:162640
- Product
- Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
- Join
- Official recall number ·
Z-1390-2018 - Root cause
- Under Investigation by firm