Core noun
Recalled products
The canonical enforcement rows. Everything else groups, enriches, or interprets these records.
Indexed record set
86,536 products
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- Product
- Plum A+3 Infusion Pump System; List Number: 12348; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care
- Firm
- Hospira Inc.
- Event
- Event 64091
- Initiated
- February 05, 2012
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- Product
- Diet Crush Orange Soda, 12 oz cans
- Firm
- Bottling LLC dba Pepsi Beverages Company
- Event
- Event 63250
- Initiated
- February 05, 2012
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- Product
- "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.
- Firm
- Orthosensor
- Event
- Event 63081
- Initiated
- February 04, 2012
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- Product
- Levothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. bottles, RX, NDC 0456-1321-01. Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
- Firm
- Lloyd Inc
- Event
- Event 61094
- Initiated
- February 03, 2012
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- Product
- Thyro-Tab 0.050mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
- Firm
- Lloyd Inc
- Event
- Event 61094
- Initiated
- February 03, 2012
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- Product
- i-Stat BNP cartridges Abbott Point of Care Inc. The i-Stat BNP test is an in vitro diagnostic test for the quantitative measurement of B-type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
- Firm
- Abbott Point Of Care Inc.
- Event
- Event 62533
- Initiated
- February 01, 2012
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- Product
- COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.
- Firm
- Roche Molecular Systems, Inc.
- Event
- Event 62586
- Initiated
- February 01, 2012
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- Product
- i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures.
- Firm
- Abbott Point Of Care Inc.
- Event
- Event 62533
- Initiated
- February 01, 2012
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- Product
- i-Stat CK-MP cartridges Abbott Point of Care Inc. The i-Stat CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI).
- Firm
- Abbott Point Of Care Inc.
- Event
- Event 62533
- Initiated
- February 01, 2012
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- Product
- Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list number 06L88-02. Language configuration bar codes - Intended Use: The bar code scanner is a hand-held device that provides a convenient means of scanning sample bar codes to allow positive sample identification and is supplementary to the computer keyboard. Both the scanner and the keyboard transmit data to a System Control Center (SCC) through a single wedge (cable with branched connectors). The bar code scanner must be configured to match the keyboard language being used. In its default configuration set by the manufacturer (Jadak), the scanner is in English format. If a keyboard other than the English keyboard is being used, the user is required to use the scanner to scan an appropriate language configuration bar code provided in the User's Guide to match the language of the keyboard. Users in the U.S have the ability to convert to another language.
- Firm
- Abbott Molecular
- Event
- Event 62329
- Initiated
- January 31, 2012
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- Product
- IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
- Firm
- Beckman Coulter Inc.
- Event
- Event 63152
- Initiated
- January 27, 2012
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- Product
- Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
- Firm
- Stryker Howmedica Osteonics Corp.
- Event
- Event 62051
- Initiated
- January 26, 2012
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- Product
- REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
- Firm
- Exactech, Inc.
- Event
- Event 62140
- Initiated
- January 24, 2012
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- Product
- REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
- Firm
- Exactech, Inc.
- Event
- Event 62140
- Initiated
- January 24, 2012
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- Product
- REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
- Firm
- Exactech, Inc.
- Event
- Event 62140
- Initiated
- January 24, 2012
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- Product
- REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
- Firm
- Exactech, Inc.
- Event
- Event 62140
- Initiated
- January 24, 2012
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- Product
- REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
- Firm
- Exactech, Inc.
- Event
- Event 62140
- Initiated
- January 24, 2012
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- Product
- REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
- Firm
- Exactech, Inc.
- Event
- Event 62140
- Initiated
- January 24, 2012
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- Product
- VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for totally adapted use in intensive care, emergencies, pediatrics, neonatology and orthopedics.
- Firm
- GE Healthcare, LLC
- Event
- Event 64759
- Initiated
- January 23, 2012
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- Product
- COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
- Firm
- Beckman Coulter Inc.
- Event
- Event 63134
- Initiated
- January 20, 2012
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- Product
- Active Renin IRMA Kit, Part Number DSL25100 Product Usage: The Renin IRMA; DSL25100 immunoradiometric assay kit provides materials for the quantitative measurement of Renin in plasma. This assay is intended for in vitro diagnostic use.
- Firm
- Beckman Coulter Inc.
- Event
- Event 63140
- Initiated
- January 20, 2012
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- Product
- Roundy's Rich Fields Butter Cookies. Product is labeled in part: Side of tin: "***RICH FIELDS*** Butter Cookies***NET WT 12 OZ (340g)***See Bottom Panel for Nutritional Information***" Bottom of tin: "***Nutrition Facts Serving Size 4 Cookies (30g)***INGREDIENTS: Wheat Flour, Sugar, Butter, Eggs, Salt, Soy Lecithin (Emulsifier) Leavening Agent (Sodium bicarbonate), Artificial Flavor.***Contains Egg, Milk, Wheat, Soy***Manufactured in a facility that process peanuts and tree nuts.***Distributed By: ATICO INTERNATIONAL USA, INC. FT. LAUDERDALE, FL 33301***MADE IN CHINA*** ROUNDY'S***205049***8 84118 12366 6***"
- Firm
- Atico International USA, Inc.
- Event
- Event 62565
- Initiated
- January 20, 2012