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Recall Observatory FDA recall evidence

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Recalled products

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Indexed record set

86,536 products

Page 3437 of 3462

Product Firm Event Initiated
Sunny Boy NoSalt Peanut Butter. No label was provided by the firm for this product. Product would have been labeled in part: "***SunnyBoy CREAMY PEANUT BUTTER***Net Wt. 35lb. (15.89KG)***Product of USA***" Marion C.I. (US Food)Lot 112012 - 12 Pails shipped. Sunshine Peanut Company Event 61291 February 17, 2012
Product is 1 oz Peanut Butter. 1 oz pouch labeled in part: "PEANUT BUTTER***Ingredients: Roaster Peanuts, Sugar, Stabilizer (Rapeseed Cottonseed and/or Soybean Oils), Salt.***Allergen Warning: Contains Peanuts***Sunshine Peanut Company Jacksonville, FL 32204***SP767***" Case label - "200/1oz PEANUT BUTTER***PRODUCT OF USA***" 200/1oz Pouch Lot 112312 - 150 cases shipped to FDC, Seatac, WA (Market Place). 500/1oz Pouch Lot 112312 - 57 cases shipped to Cheney Brothers. Ocala, FL. Sunshine Peanut Company Event 61291 February 17, 2012
Sunny Boy Peanut Butter. Product is labeled in part: 6/5 lb tubs- "SunnyBoy Creamy PEANUT BUTTER***Net Wt. 5lb. (2.27KG)***INGREDIENTS: Peanuts, Dextrose, Contains less than 2% of the following: Salt, Partially Hydrogenated Oil (Rapeseed Cottonseed And/Or Mono-Diglycerides)***Allergen Statement: CONTAINS PEANUTS***Sunshine Peanut Company Tampa, FL 33637*** -- Driscoll product 1,344 cases Lot 111912 & 112012. 35 lb pail labeled in part: ""SunnyBoy Creamy PEANUT BUTTER***Net Wt. 35lb. (15.89KG)***INGREDIENTS: Peanuts, Dextrose, Contains less than 2% of the following: Salt, Partially Hydrogenated Oil (Rapeseed Cottonseed And/Or Mono-Diglycerides)***Allergen Statement: CONTAINS PEANUTS***Sunshine Peanut Company Tampa, FL 33637*** -- South Bay Correctional Facility, South Bay, FL (Good Source) 72 Pails Lot 112412. Sunshine Peanut Company Event 61291 February 17, 2012
Product is 50 lb Bag Peanut Butter. Product Case is labeled in part: "***50 Lbs Bag***PEANUT BUTTER***PRODUCT OF USA*** 50 Lb Bag Lot 113112 - 225 boxes shipped to Cheney Brothers, Ocala, FL. ----------- 10/5 Lbs Bag Peanut Butter. Product Case is labeled in part: "***10/5 Lbs Bag PEANUT BUTTER***PRODUCT OF USA***" 10 / 5 Lb Bags Lot 113112 - 48 boxes shipped to Cheney Brothers, Ocala, FL. Sunshine Peanut Company Event 61291 February 17, 2012
Sunny Boy Low Sodium/ Low Salt Peanut Butter. Product is labeled in part: 35 lb pail labeled in part: ""SunnyBoy LowSodium/LowSalt***PEANUT BUTTER***Net Wt. 35lb. (15.89 KG)***INGREDIENTS: Peanuts, Dextrose, Contains less than 2% of the following: Partially Hydrogenated Oil (Rapeseed Cottonseed And/Or Mono-Diglycerides)***Allergen Statement: CONTAINS PEANUTS***Sunshine Peanut Company Tampa, FL 33637*** US Food Service, Boca Raton, FL Lot 113012 Qty 846 pails. Sunshine Peanut Company Event 61291 February 17, 2012
Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic cap. R2: PE plastic bottle w /PP plastic cap. Product Usage: Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers. Medtest Holdings, Inc. Event 76985 February 15, 2012
Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. Smiths Medical ASD, Inc. Event 61247 February 14, 2012
Fenugreek, 3 dozen per case. Daaks International Event 63341 February 13, 2012
The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ¿ssur. Both are a battery powered micro-processor controlled prosthetic device and are connected through a shared battery. The knee and the foot have different sensor systems that provide real-time information used to control knee joint resistance and the flexion/extension of the ankle during the gait cycle. Default control parameters are provided with the device but can be manually adjusted by a certified prosthetist through software (knee), or by a certified prosthetist or the user through controls on the device itself (foot). SYMBIONIC LEG is intended for continuous use by amputees of low to moderate impact levels that weigh less than 125 kg for foot categories 25  30 and less than 100kg for foot Categories 22, 23 and 24. The system is not intended for athletic use. Ossur Americas, Inc. Event 67249 February 12, 2012
Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. Covidien LLC dba Uni-Patch Event 61209 February 09, 2012
Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation. Covidien LLC dba Uni-Patch Event 61209 February 09, 2012
Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation. Covidien LLC dba Uni-Patch Event 61209 February 09, 2012
Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation. Covidien LLC dba Uni-Patch Event 61209 February 09, 2012
Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthrodesis, Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint. Integra LifeSciences Corp. Event 61655 February 09, 2012
The finger cots are made out of natural rubber. They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry. Cots are packed in clear plastic boxes, with 60 cots in a box They are disposable products used to cover a fingertip bandage when working with liquids and are intended to keep the fingertip bandage dry Afassco Inc Event 62645 February 08, 2012
Lipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa OK 74146, NDC 54868-4229-0 Physicians Total Care, Inc. Event 62239 February 08, 2012
CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled products of Cavicide: Backscratchers Cavicide, part number: 13-4800. MaxiSpray Plus, part numbers: 13-7400 and 13-7405. pdCARE Surface Disinfectant, part numbers: 13-7525 and 13-7500. Z3 Surface Disinfectant, part number: 13-7900. CaviCide is a multi-purpose disinfectant/decontaminant cleaner for use on hard, non-porous inanimate surfaces. CaviCide is a bactericidal, virucidal, fungicidal, and tuberulocidal which is available in a ready-to-use, liquid form typically contained in 1 gallon bottles, 2.5 gallon bottles, 25 oz. spray bottles, or 55 gallon drums (depending on the item number). CaviCide may also be branded as a private label (see (1)(vi) below for names and Table 1 above for additional details). The product may be used (1) for precleaning non-instrument surfaces prior to disinfection; (2) for precleaning instruments prior to disinfection; (3) as a virucide on non-instrument surfaces; (4) as a disinfectant on non-instrument surfaces; (5) as a virucide on precleaned non-critical medical devices, instruments and implements; and (6) as a disinfectant on precleaned non-critical medical devices, instruments, and instruments. It is useful in health care settings such as hospitals, emergency medical settings, surgical centers, isolation areas, neonatal units, patient care areas, ophthalmic and optometric facilities, dental offices, dental operatories, animal care facilities, salon settings, emergency vehicles, schools, health club facilities, kitchens, bathrooms, prisons, morgues, and other critical care areas. Metrex Research, LLC. Event 62864 February 06, 2012
VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator. Accumetrics Inc Event 61761 February 06, 2012
VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator. Accumetrics Inc Event 61761 February 06, 2012
Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20 sanofi-aventis US, Inc. Event 62350 February 06, 2012
Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10 sanofi-aventis US, Inc. Event 62350 February 06, 2012
Plum A+ Infusion Pump; List Number: 12618; 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 Hospira Inc. Event 64091 February 05, 2012
*** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; for use with Hospira MedNet; *** 3) Plum A+ Infusion Pump with Hospira MedNet Software; List Number: 20792; Labeled in part: PLUM A+; for use with Hospira MedNet; 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 Hospira Inc. Event 64091 February 05, 2012
Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; 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 Hospira Inc. Event 64091 February 05, 2012
Plum A+ Infusion Pump; List Number: 11971; 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 Hospira Inc. Event 64091 February 05, 2012

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