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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 3407 of 3462

Product Firm Event Initiated
Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Intellispace Portal is a medical software system that allows multiple users to remotely access the system from compatible computers on a network. Philips Medical Systems (Cleveland) Inc Event 62128 May 22, 2012
Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens. Alere San Diego, Inc. Event 61927 May 22, 2012
4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 38MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface). Synthes USA HQ, Inc. Event 62307 May 22, 2012
Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens. Alere San Diego, Inc. Event 61927 May 22, 2012
Da Vinci Pesto Genovese with basil and pine nuts Net Wt. 10 oz. (283 g) Distributed by World Finer Foods, Inc. Bloomfield, NJ 07003 Product is packaged in a glass jar with lid. www.worldfiner.com Product of Italy UPC: 0 70670-00822 4 World Finer Foods, Inc. Event 63200 May 22, 2012
Shiitake-Ya brand Dried Shiitake mushroom slices, 6 oz plastic jars, UPC 7 1452 22183 9. Product labeling reads in part: " Shiitake-Ya gourmet Shiitake SLICES***Antioxidants Amino Acids Omega 3+6***Immune-Boosting*** NET WEIGHT. 6 oz (170 g)***Natural Enzymes Fiber (80% Chitin) Iron Kojic Acid LA Link Corporation Event 61937 May 22, 2012
Tempeh Super Starter Yeast, Rhizopus Oligosporus cultures, soybean rice flour, packaged in clear plastic packages in 30 gm, 50 gm, 250 gm, and 1000 gm sizes and labeled in part ***Indonesianfoodmart.com*** Indonesian Food Mart Event 62290 May 22, 2012
Tempeh Starter Yeast, Rhizopus Oligosporus cultures, soybean rice flour, Original, packaged in clear plastic packages in 30gm, 50gm, 250 gm, and 1000 gm sizes and labeled in part ***Indonesianfoodmart.com*** Indonesian Food Mart Event 62290 May 22, 2012
Private Selections Organic Baby Spinach, 5 oz plastic clamshell, UPC 0-11110-91128-5; Marketside Baby Spinach Organic, 10 oz plastic clamshell, UPC: 6-8113132900-2 Taylor Farms Retail, Inc. Event 61911 May 22, 2012
Luna & Larry's Coconut Bliss Mocha Maca Crunch; UPC 8 96767 00143 1 Bliss Unlimited Event 62554 May 22, 2012
Cheese Lasagna Rolls; Perishable, keep frozen; Net weight 15 pounds, 60 x 4 oz. For HRI Use Only. Cook Thoroughly per state food code standards. West Best Foods, inc. 3425 Wynn Road, Las Vegas, NV 89102 Best West Foods Event 61968 May 22, 2012
Florentine Lasagna Rolls; Perishable, keep frozen; Net weight 15 pounds, 60 x 4 oz. For HRI Use Only. Cook Thoroughly per state food code standards. West Best Foods, inc. 3425 Wynn Road, Las Vegas, NV 89102 Best West Foods Event 61968 May 22, 2012
Frozen Half Shell Oysters(S) and Frozen Half Shell Oysters(M) Rong Chang Trading LLC dba: Always Best Event 62366 May 22, 2012
Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE). The Cool-Cap is indicated for use in full term infants (more than 36 week gestational age) with clinical evidence of moderate to severe HIE. The device provides selective head cooling with mild systemic hypothermia to prevent or reduce the severity of neurologic injury associated with HIE. It is a selective head cooling system for treatment of neonatal hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. The device is labeled in part: "***OLYMPIC COOL-CAP Cooling Unit***Model No.***Made in USA***Software in this product is Natus Medical Incorporated***" Natus Medical Incorporated Event 61946 May 21, 2012
Philips Multi Diagnost Eleva II with swivel cable Product Codes; 708032, 708036 Multi Diagnost Eleva with FlatDetector with swivel cable Product Codes: 708034, 708037 This Philips MultiDiagnost Eleva system is intended to be used as a multifunctional/ universal system. General R/F, performed along with more specialized interventional applications. This includes the following general areas: Digestive system Skeletal system Urinary system Reproductive system Respiratory system Circulatory system Various . Arthrograms . Myelograms . Facet joint injections . Discography SialographyFluoroscopy, Radiography and Angiography Philips Healthcare Inc. Event 62052 May 21, 2012
VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest. Ortho-Clinical Diagnostics Event 61910 May 21, 2012
Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe. Stryker Endoscopy Event 61955 May 21, 2012
VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest. Ortho-Clinical Diagnostics Event 61910 May 21, 2012
VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest. Ortho-Clinical Diagnostics Event 61910 May 21, 2012
Hands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS Industries, Crestwood, IL, 60446 Kutol Products Co Inc Event 61960 May 21, 2012
TROCAR KIT, STERILE DISPOSABLE** DEVICE 1 KIT 1 PELLET 2 KIT 3 KIT 4 KIT 5 KITS 6 KIT (7 DIFFERENT PRODUCTS) Franck's Lab Inc., d.b.a. Franck's Compounding Lab Event 62443 May 21, 2012
POVIDONE-IODINE OPHTHALMIC 5% SOLUTION 10 ML 125 ML 15 ML 40 ML 50 ML; POVIDONE-IODINE, BUFFERED IN BSS 4.6% OPHTHALMIC 100 ML 120 ML 200 ML (8 DIFFERENT PRODUCTS) Franck's Lab Inc., d.b.a. Franck's Compounding Lab Event 62443 May 21, 2012
TETRACOSACTIDE ACETATE (COSYNTROPIN) 0.25MG/ML INJECTABLE 1 ML (1 PRODUCT) Franck's Lab Inc., d.b.a. Franck's Compounding Lab Event 62443 May 21, 2012
IOHEXOL 200MG IODINE/ML INJECTABLE 120 ML 300 ML 50 ML 600 ML 72 ML; IOHEXOL, 4ML VIAL 240MG IODINE/ML INJECTABLE 200 ML; IOHEXOL, 3ML VIAL 300MG IODINE/ML INJECTABLE 180 ML 600 ML 90 ML 900 ML (10 DIFFERENT PRODUCTS) Franck's Lab Inc., d.b.a. Franck's Compounding Lab Event 62443 May 21, 2012
MIC - COMBO WITH METHYLCOBALAMIN 0.8/1.6/1.6/0.0001/0.03% INJECTABLE 10 ML 150 ML 30 ML; MIC COMBO + CHORIONIC GONADOTROPIN + B12 500U/40MCG/ML (125U/10MCG/0.25ML) INJEC 6 ML; MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED 10,000 UNIT VIAL INJECTABLE 1 VIAL 10 VIAL 15 VIAL 2 VIAL 20 VIAL 4 VIAL 40 VIAL 5 VIAL 50 VIAL 6 VIAL 7 VIAL 8 VIAL MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) 10,000 UNIT VIAL INJECTABLE 1 KIT 2 KIT 4 KIT MIC COMBO + CHORIONIC GONADOTROPIN, LYOPHILIZED(KIT) II 10,000 UNIT VIAL INJECTA 1 KIT (20 DIFFERENT PRODUCTS) Franck's Lab Inc., d.b.a. Franck's Compounding Lab Event 62443 May 21, 2012

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