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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 1554 of 1581

Evidence Product Join Root cause
device-recall:cfres:131253 Cannulaide, Model 101. The Cannulaide product is composed of die-cut hydrocolloid coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose. It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on infants ranging from less than 700 grams to greater than 3000 grams. It is a non sterile, single patient use, disposable device. Official recall number · Z-0487-2015 Labeling Change Control
device-recall:cfres:131344 GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006. Official recall number · Z-0493-2015 Mixed-up of materials/components
device-recall:cfres:131467 ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR Official recall number · Z-0456-2015 Device Design
device-recall:cfres:114969 Medium 2-Hooks Spreader Bar for use with Loop Slings, sizes small, medium and large on the Maxi Sky 2 Ceiling Lift; Model 700-19425. Intended to be used for general transfers in hospitals. Official recall number · Z-0079-2015 Device Design
device-recall:cfres:130185 eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (including but not limited to CT,MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm Workstation can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record. Official recall number · Z-0068-2015 Device Design
device-recall:cfres:129993 VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Official recall number · Z-0078-2015 Software design
device-recall:cfres:131299 GDC-10 360 10mm x 30cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable Official recall number · Z-0479-2015 Process control
device-recall:cfres:131158 Cesarean Pack, Catalog number 900-403. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Official recall number · Z-0377-2015 Packaging
device-recall:cfres:131140 Laparotomy Surgical Pack, catalog #900-281A Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Official recall number · Z-0362-2015 Packaging
device-recall:cfres:131022 Laparoscopy Chole Pack, Catalog number 900-1059. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Official recall number · Z-0272-2015 Packaging
device-recall:cfres:131428 AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated. Official recall number · Z-0464-2015 Software in the Use Environment
device-recall:cfres:131137 Bandeja para Debridacion (Debridement Tray), Catalog #900-2702 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Official recall number · Z-0359-2015 Packaging
device-recall:cfres:131078 Laparoscopy Premium Pack, Catalog number 900-1803. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Official recall number · Z-0316-2015 Packaging
device-recall:cfres:131114 Cystoscopy Pack III, catalog #900-2482 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Official recall number · Z-0342-2015 Packaging
device-recall:cfres:131023 Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T8-L5). Official recall number · Z-0226-2015 Process control
device-recall:cfres:130669 Skin Staple Removal, Catalog number 900-782. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Official recall number · Z-0250-2015 Packaging
device-recall:cfres:131193 Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits Official recall number · Z-0425-2015 Mixed-up of materials/components
device-recall:cfres:130168 ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma. Official recall number · Z-0474-2015 Employee error
device-recall:cfres:131151 Face Lift, Catalog number 900-3083. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Official recall number · Z-0372-2015 Packaging
device-recall:cfres:131436 Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients. Official recall number · Z-0485-2015 Device Design
device-recall:cfres:131071 OB Pack, Catalog number 900-1717. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Official recall number · Z-0309-2015 Packaging
device-recall:cfres:130649 Suction Catheter Kit, Catalog number 900-277. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Official recall number · Z-0243-2015 Packaging
device-recall:cfres:131223 Femoral Angiography Pack, Catalog number 900-796. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Official recall number · Z-0402-2015 Packaging
device-recall:cfres:131056 ENT Pack, Catalog number 900-1482. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Official recall number · Z-0294-2015 Packaging
device-recall:cfres:131018 OB Pack, Catalog number 900-1030. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. Official recall number · Z-0270-2015 Packaging

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