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Recall Observatory FDA recall evidence

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Recalled products

The canonical enforcement rows. Everything else groups, enriches, or interprets these records.

Indexed record set

86,536 products

Page 3394 of 3462

Product Firm Event Initiated
T.G.I. Friday's Mozzarella Sticks 2.25oz, 3.5oz, and 4.8 oz. Item#30187, 30588, 30588B, 30707, 30819, 30834. Inventure Foods Event 62330 June 08, 2012
Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional. Model number is 3403644. The intended use of this tray is to provide the surgeon, nurse or other licensed medical professional, a kit of sterile instruments, drugs and other medical materials that will support the administration of anesthesia, be it local, spinal or general administration. Integra LifeSciences Corp. d.b.a. Integra Pain Management Event 61525 June 07, 2012
Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections. Arrow International Inc Event 62125 June 07, 2012
Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R) CS Acute Care(TM) D-dimer )DDMR) method Siemens Healthcare Diagnostics, Inc. Event 62712 June 07, 2012
EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-Vitro diagnostics devices. Siemens Healthcare Diagnostics, Inc. Event 62448 June 07, 2012
Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments Siemens Healthcare Diagnostics, Inc. Event 62403 June 07, 2012
Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc., Melville, New York 11747, NDC 0168-0215-60, UPC 3 0168-0215-60 0. Fougera Pharmaceuticals, Inc. Event 62136 June 07, 2012
SunFresh Natural Pitted Prunes Net wt. 6 oz. Distributed by: Sunfresh Natural LLC, Passaic, NJ 07055 Please visit us at: www.sunfreshnatural.com SUNFRESH NATURAL LLC. Event 63203 June 07, 2012
Kettle Brand Potato Chips, Krinkle Cut Cheddar and Sour Cream; 1) 6/2 oz (caddy) item # 0711770000, UPC 0 8114 11715 1; 2) 24/2 oz item # 0711714000, UPC 0 84114 11715 1; 3) 15/5 oz item # 0711718000, UPC 0 84114 11719 9; 4) 12/8.5 oz item #'s 0711726001 and 0711726500 (different numbers for different geographical locations of distribution), UPC 0 84114 11728 1; 5) 10/13 oz item # 0711716001, UPC 0 84114 11717 5; 6) 12/220 g item # 0711915000, UPC 0 84114 1190 5; 7) 10/397g item # 0711729000, UPC 0 84114 11731 1. Kettle Foods, Inc. Event 62291 June 07, 2012
Sienna Bakery¿ Oatmeal Walnut Raisin Gourmet Cookies, UPC 093901165992, NET WT /PESO NETO 54 OZ (3.38 LB) 1.52 kg, 40 Count Thaw & Serve, INGREDIENTS: ENRICHED WHEAT FLOUR, RAISINS, BROWN SUGAR, OATS, WALNUTS, BUTTER, WHOLE EGGS, MARGARINE(PARTIALLY HYDROGENATED SOYBEAN AND COTTONSEED OILS, WATER, SALT, BUTTERMILK, LECITHIN, VEGETABLE MONO AND DIGLYCERIDES, SORBIC ACID & SODIUM BENZOATE ADDED AS PRESERVATIVE ARTIFICIALLY FLAVORED, ARTIFICIALLY COLORED WITH BETA CAROTENE, VITAMIN A PALMITATE ADDED), INVERT SUGAR, VANILLA (WATER, ETHYL ALCOHOL, CARMEL COLOR) CINNAMON, SODA BICARBONATE, SALT, CARMEL COLOR.), CONTAINS: MILK, EGG TREE NUT (WALNUT), SOY, Distributed by / Distribuido por Gordon Food Services, Grand Rapids, MI 49548 Minnesota Best Maid Cookie Co, Inc. Event 62345 June 07, 2012
Sienna Bakery¿ White Chocolate Macadamia Nut Gourmet Cookies, UPC 093901201706, NET WT /PESO NETO 54 OZ (3.38 LB) 1.52 kg, 40 Count Thaw & Serve, INGREDIENTS: ENRICHED WHEAT FLOUR, CHOCOLATE FLAKES (SUGAR, COCOA, BUTTER, WHOLE MILK POWDER, SKIM MILK POWDER, MILK FAT, SOY LECITHIN ADDED AS EMULSIFIER, VANILLA EXTRACT), BROWN SUGAR, WHITE SUGAR, WHITE CHUNK ( SUGAR, PARTIALLY HYDROGENATED PALM KERNEL AND PALM OILS, NONFAT DRY MILK, BUTTERFAT, SOY LECITHIN, ADDED AS EMULSIFIER, SALT AND ARTIFICIAL FLAVORING ADDED) BUTTER, WHOLE EGGS, MARGARINE(PARTIALLY HYDROGENATED SOYBEAN AND COTTONSEED OILS, WATER, SALT, BUTTERMILK, LECITHIN, VEGETABLE MONO AND DIGLYCERIDES, SORBIC ACID & SODIUM BENZOATE ADDED AS PRESERVATIVE ARTIFICIALLY FLAVORED, ARTIFICIALLY COLORED WITH BETA CAROTENE, VITAMIN A PALMITATE ADDED), M ACADEMIA NUTS, INVERT SUGAR, VANILLA (WATER, ETHYL ALCOHOL, CARMEL COLOR) , SALT, SODA BICARBONATE, CARMEL COLOR.), CONTAINS: WHEAT, MILK, EGG TREE NUT (MACADAMIA), SOY, Distributed by / Distribuido por Gordon Food Services, Grand Rapids, MI 49548 Minnesota Best Maid Cookie Co, Inc. Event 62345 June 07, 2012
Kettle Brand Potato Chips, New York Cheddar; 1) 24/1.5oz, item # 0712278000, UPC 0 8114 11271 2; 2) 24/2 oz item # 0703320000 UPC 0 84114 03320 8; 3) 15/5 oz item # 0710863000, UPC 0 84114 0094 1; 4) 12/8.5 oz item #'s 0710813001 and 0710813500 (different numbers for different geographical locations of distribution), UPC 0 84114 10813 5; 5) Canadian item 12/220 g item # 0711920000, UPC 0 84114 11907 0; 6) 100/5 oz as part of a display, item # 0703450000; 7) Shipper containing 48/8.5 oz, item # 0711651001. Kettle Foods, Inc. Event 62291 June 07, 2012
F-Tara Saikyozuke (Cod Fish with miso), 3.1lb., 20pc.x ab.2.5oz. Mutual Trading Company Inc Event 62277 June 07, 2012
Kettle Brand Potato Chips, Sour Cream and Onion, 12/8.5oz, item # 0711387001, UPC 0 84114 11393 1 Kettle Foods, Inc. Event 62291 June 07, 2012
Kettle Brand Potato Chips, Cheddar Beer, item #0712374000, UPC 0 84114 12375 6. Kettle Foods, Inc. Event 62291 June 07, 2012
Siemens syngo.plaza radiological image processing system. Siemens Medical Solutions USA, Inc Event 63045 June 06, 2012
ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting. Sendx Medical Inc Event 60514 June 06, 2012
AirLife¿ MiniSpacer¿ MDI Dispenser Adapter. Dual-Spray MiniSpacer¿ Metered Dose Inhaler (MDI) Dispenser/Adapter with 15 mm connections. The 15 mm Dual Spray MiniSpacer¿ is a Metered Dose Inhaler (MDI) Dispenser. It is a non-sterile, single-use item, intended to dispense aerosolized medication into a breathing circuit or ancillary circuits. MINISPACER adapters are indicated for patients on a breathing circuit, for whom aerosol medication has been prescribed, in short and long term critical care environments. The 15 mm device is installed and operated by licensed healthcare practitioners in clinical settings. The MiniSpacer is not a metering valve, and does not measure the amount of medication dispensed. The device may also be used in conjunction with a resuscitator bag or in-line with cool or heated humidification, oxygen enriched T-pieces (blow-by) systems connected to tracheal/endotracheal tube. Environments of use include short and long term critical care settings. The 15 mm Dual Spray MiniSpacers design provides standard dimension connectors (15 mm outer diameter x 15 mm inner diameter) for connection to the ventilator circuit. The device design incorporates a dual spray nozzle that allows a path for the medication to travel through the stem and directs it through the dual orifices into the airstream. Principles of Operation A healthcare practitioner installs the 15 mm MiniSpacer MDI adapter in the breathing circuit, according to facility procedures or as ordered by a physician or other licensed health care practitioner. To dispense the prescribed medication, the healthcare practitioner inserts the MDI canister stem into the devices actuator port and manually depresses the MDI canister. The MDI canisters metering valve releases the combination of medication and propellant through the valve stem and out of the devices dual spray nozzle. The plume is simultaneously ejected through upstream and downstream spray orifices along the longitudinal axis of the device. The practitioner administers the medication as prescribed, caps the MiniSpacer device, and monitors the patient response. The devices are packaged in cardboard corrugated cartons that are rated to meet burst testing up to 200 pounds per square inch. Each carton contains 30 devices; each device is packaged in a polybag with the instructions for use. These devices are sold non-sterile. Thayer Medical Corporation Event 62283 June 06, 2012
Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature. Zoe Medical Incorporated Event 62939 June 06, 2012
Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular involvement. Edwards Lifesciences, LLC Event 52194 June 06, 2012
Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15-count autoinjectors per carton, Rx only, Meridian Medical Technologies, Columbia, MD 21046; A subsidiary of King Pharmaceuticals, Inc.; NSN 6505-01-274-0951, NDC 11704-600-01. Meridian Medical Technologies a Pfizer Company Event 62015 June 06, 2012
Reggano, Linguine and Parmesan Pasta Entree, NET WT 4.8 OZ(136g), UPC 4149813345, Distributed by ALDI Inc., Batavia, IL 60510. TreeHouse Foods, Inc / Bay Valley Foods Event 62306 June 06, 2012
H.E.B Pasta Salad Ranch & Bacon, NET WT 7.5 OZ , CONT. NET 212G, UPC 4122089106 TreeHouse Foods, Inc / Bay Valley Foods Event 62306 June 06, 2012
Reggano Pasta Salad Classic, UPC 4149812863, Distributed by ALDI Inc., Batavia, IL 60510. TreeHouse Foods, Inc / Bay Valley Foods Event 62306 June 06, 2012
Great Value, Thick and Creamy Macaroni and Cheese , NET WT 7.25 OZ (206g), UPC 7874223061, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716 TreeHouse Foods, Inc / Bay Valley Foods Event 62306 June 06, 2012

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