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:184546
- Product
- Three IceFORCE" 2.1 CX Prostate Cryoablation Kit
- Join
- Official recall number ·
Z-0684-2021 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:184853
- Product
- Revolution CT ES - Product Usage: intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
- Join
- Official recall number ·
Z-0694-2021 - Root cause
- Software in the Use Environment
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- Evidence
- device-recall:cfres:184535
- Product
- IceSeed" 1.5 Cryoablation Needle
- Join
- Official recall number ·
Z-0676-2021 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:184541
- Product
- IceFORCE" 2.1 CX Prostate Cryoablation Kit
- Join
- Official recall number ·
Z-0682-2021 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:184611
- Product
- icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.
- Join
- Official recall number ·
Z-0859-2021 - Root cause
- Software design
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- Evidence
- device-recall:cfres:184984
- Product
- All EPIQ and Affiniti Ultrasound systems. Model numbers - EPIQ 5G, EPIC 5C, EPIQ 5W, EPIQ 7G, EPIC 7C, EPIQ 7W, EPIQ CVx, Affiniti 30, Affiniti 50, Affiniti 70. Diagnostic Ultrasound System. MOD - EPIQ 5 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 7 GMDN - 40761 100-240V 50/60 Hz, 600 VA MOD - EPIQ 100-240V 50/60 Hz, 600 VA MOD - Affinity 30 GMDN - 40761 100-240V 50/60 Hz, 450 VA MOD - Affinity 50 GMDN - 40761 100-240V 50/60 Hz, 450 VA MOD - Affinity 70 GMDN - 40761 100-240V 50/60 Hz, 450 VA
- Join
- Official recall number ·
Z-0864-2021 - Root cause
- Software design
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- Evidence
- device-recall:cfres:184863
- Product
- Naturalyte Liquid Acid concentrate bottles, Product Code 08-2201-5 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
- Join
- Official recall number ·
Z-0832-2021 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:185046
- Product
- VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems Product Code: 8392292
- Join
- Official recall number ·
Z-0844-2021 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:185073
- Product
- ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
- Join
- Official recall number ·
Z-0870-2021 - Root cause
- Process control
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- Evidence
- device-recall:cfres:184866
- Product
- Citrasate Liquid Acid concentrate bottles, Product Code 08-2251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
- Join
- Official recall number ·
Z-0834-2021 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:184693
- Product
- NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2231-2 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
- Join
- Official recall number ·
Z-0814-2021 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:184953
- Product
- Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
- Join
- Official recall number ·
Z-0863-2021 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:185079
- Product
- Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
- Join
- Official recall number ·
Z-0911-2021 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:185072
- Product
- Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
- Join
- Official recall number ·
Z-0905-2021 - Root cause
- Device Design
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- Evidence
- device-recall:cfres:184723
- Product
- EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
- Join
- Official recall number ·
Z-0935-2021 - Root cause
- Process change control
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- Evidence
- device-recall:cfres:185535
- Product
- SARS-CoV-2 Antigen Test
- Join
- Official recall number ·
Z-0941-2021 - Root cause
- Under Investigation by firm
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- Evidence
- device-recall:cfres:183678
- Product
- GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
- Join
- Official recall number ·
Z-0291-2021 - Root cause
- Process control
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- Evidence
- device-recall:cfres:182809
- Product
- 47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121154(17)250101(30)25(10)4556714; (01)10887709121154(17)250101(30)25(10)4573639. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
- Join
- Official recall number ·
Z-0234-2021 - Root cause
- Process control
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- Evidence
- device-recall:cfres:182799
- Product
- 3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10)4556715; (01)10887709087153(17)250101(30)50(10)4579939; (01)10887709087153(17)250101(30)50(10)4592179; (01)10887709087153(17)250101(30)50(10)4610925; (01)10887709087153(17)241201(30)50(10)4547212; (01)10887709087153(17)250101(30)50(10)4712946; (01)10887709087153(17)250201(30)50(10)4720392. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
- Join
- Official recall number ·
Z-0224-2021 - Root cause
- Process control
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- Evidence
- device-recall:cfres:182812
- Product
- 10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709067322(17)250101(30)50(10)4565730; (01)10887709067322(17)250201(30)50(10)4713953; (01)10887709067322(17)250201(30)50(10)4730099; (01)10887709067322(17)250101(30)50(10)4599979; (01)10887709067575(17)250101(30)50(10)4589962; (01)10887709067575(17)250201(30)50(10)4711191;(01)10887709067575(17)250201(30)50(10)4733727. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
- Join
- Official recall number ·
Z-0235-2021 - Root cause
- Process control
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- Evidence
- device-recall:cfres:182948
- Product
- SURPLUG Nano Connector.1 unit per pouch, 100 multivac pouches per case. UDI:(01)54987892069913(17)221201(30)100(10)4476418. Administration sets and their accessories are single use, pre-sterilized devices that provide access for the administration of fluids from a container to a patient s vascular system through the administrations set needle or catheter, which is inserted into the vein.
- Join
- Official recall number ·
Z-0280-2021 - Root cause
- Process control
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- Evidence
- device-recall:cfres:182795
- Product
- Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053189(17)241201(30)50(10)4537253;(01)10887709053189(17)250101(30)50(10)4557545. The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.
- Join
- Official recall number ·
Z-0220-2021 - Root cause
- Process control
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- Evidence
- device-recall:cfres:182689
- Product
- 6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case; UDI: (01)10887709051031(17)250101(30)50(10)4605103;(01)10887709051031(17)250201(30)50(10)4733543 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein).
- Join
- Official recall number ·
Z-0184-2021 - Root cause
- Process control
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- Evidence
- device-recall:cfres:183753
- Product
- TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product Number: 7210309
- Join
- Official recall number ·
Z-0136-2021 - Root cause
- Equipment maintenance
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- Evidence
- device-recall:cfres:183791
- Product
- HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product Number: 72203705
- Join
- Official recall number ·
Z-0169-2021 - Root cause
- Equipment maintenance