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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 1524 of 1581

Evidence Product Join Root cause
device-recall:cfres:166557 SCNB4TK CONT STIM W/4 INCH INSUL TUOHY, Material Number 331756 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-3325-2018 Under Investigation by firm
device-recall:cfres:166597 CE18TIN CONT EPIDURAL SET LF, Material Number 332201 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-3351-2018 Under Investigation by firm
device-recall:cfres:166861 Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659 Official recall number · Z-0035-2019 Nonconforming Material/Component
device-recall:cfres:166637 EPID PAED FULL KIT 24GA CT NG CATH LF, Material Number 332292 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-3383-2018 Under Investigation by firm
device-recall:cfres:166546 CNBFX350O CONTIPLEX CONT NERVE BLOCK, Material Number 331670 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-3314-2018 Under Investigation by firm
device-recall:cfres:166480 smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients. Official recall number · Z-0073-2019 Labeling design
device-recall:cfres:166551 CONTIPLEX TUOHY SET, 18GX4", 1.3X100MM, Material Number 331693 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-3319-2018 Under Investigation by firm
device-recall:cfres:166848 CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02 Official recall number · Z-0022-2019 Nonconforming Material/Component
device-recall:cfres:166858 Capnostream20 (US) N REFURBISHED, Part Number CS78651 Official recall number · Z-0032-2019 Nonconforming Material/Component
device-recall:cfres:166608 CE18TK ACCU-BLOC PERIFIX KIT, Material Number 332220 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-3362-2018 Under Investigation by firm
device-recall:cfres:167075 ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 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). Official recall number · Z-0069-2019 Device Design
device-recall:cfres:166642 GOVES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 332614 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-3388-2018 Under Investigation by firm
device-recall:cfres:166993 Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds. Official recall number · Z-0017-2019 Nonconforming Material/Component
device-recall:cfres:166857 Capnostream20 (US) M W/PRINTER TO MASIMO, Part Number CS08751 Official recall number · Z-0031-2019 Nonconforming Material/Component
device-recall:cfres:165749 ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery. Official recall number · Z-0011-2019 Process control
device-recall:cfres:160537 PROPONENT SR Pacemaker Official recall number · Z-0373-2018 Device Design
device-recall:cfres:161023 Brilliance iCT - Model 728306 Computed Tomography X-ray systems Official recall number · Z-0403-2018 Software design
device-recall:cfres:157839 Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids. Official recall number · Z-0313-2018 Component design/selection
device-recall:cfres:159896 UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. Official recall number · Z-0310-2018 Device Design
device-recall:cfres:161320 JS Series SterilContainer S2 System Official recall number · Z-0624-2018 No Marketing Application
device-recall:cfres:161228 Norian Drillable Inject Official recall number · Z-0617-2018 Process control
device-recall:cfres:160940 ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons. Official recall number · Z-0639-2018 Software design
device-recall:cfres:160979 Covidien Vistec" X-Ray Detectable Sponges, 7317 Vistec" X-Ray Detectable Sponges Sponge. product Usage: Vistec X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain unique dual-colored elements that combines blue radiopaque strand with white strand, which is visible when sponge is saturated with blood. Official recall number · Z-0534-2018 Material/Component Contamination
device-recall:cfres:160796 Contiplex Nerve Block Tray. Product Catalog Number: 570205. Local anesthesia of the skin prior to insertion of the regional anesthesia needle. Official recall number · Z-0576-2018 Material/Component Contamination
device-recall:cfres:158599 Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool Official recall number · Z-0603-2018 Nonconforming Material/Component

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