Worldwide Distribution - US: Nationwide + American Samoa + District of Columbia + Guam + Northern Mariana Islands + Puerto Rico; *** FOREIGN: Antigua, Argentina, Australia, Bahamas, Barbados, Bermuda, Brazil, Canada, Chile, Colombia, Cuba, Curacao, Dominican Republic, Ecuador, El Salvador, France (New Caledonia), Guatemala, Guyana, Honduras, Hong Kong, India, Indonesia, Jamaica, Japan, Macau, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Suriname, Taiwan, Thailand, Trinidad and Tobago, United Kingdom (Cayman Islands), Uruguay, Venezuela
MiniCap Extended Life PD Transfer Set Extra Short (4'') with Twist Clamp. Product Code: 5C4483.    intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.
Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex.
MiniCap Extended Life PD Transfer Set  (6'') with Twist Clamp. Product Code: 5C4482.  intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.
MiniCap Extended Life PD Transfer Set. Product Code 5C4449.    intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.
CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160.     intended for use with containers of DIANEAL peritoneal dialysis solution.
Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, , Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-015-66, UPC 63824-01565-1
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Diphenhydramine HCl Antihistamine/Cough Suppressant, Phenylephrine HCl Nasal Decongestant, 6 fl oz. (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-500-66, UPC 63824-50066-09
Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-016-66, UPC 63824-01665-8
Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz (180 mL) bottles Total -12 fl oz (360 mL), For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224  Made in India, NDC 63824-526-22
Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-014-66, UPC 6382401465-4
Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl oz (360 mL), For Ages 12+, Dist. by Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-528-22-01, NDC 63824-528-22-00, UPC 63824-52822-9
Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-019-66, UPC 63824-01966-9, UPC 63824-52622-5
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood products, collected in a manner lacking assurance of sterility, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Distributed in CA, MI, MA, NC, NJ, NY, PA, TN, TX, PA & WI.
PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics.
In some cases, especially with high dose-per-pulse-rates typical for particle (specifically proton) therapy, measuring errors can result. Individual measurement intervals can be lost that are not visible to the user when there is a high dose-per-pulse rate resulting in a too-low dose being displayed on the monitor. This could result in a radiation over-exposure.
Rato Bhale Nepali Finger Chips  Product of Nepal  Weight: 200g (7.05 OZ)  Imported by:  Balajee Trade Link, LLC, PA USA    Batch No. 01-15
Nepali Finger Chips contains undeclared tartrazine (yellow #5).
Distributed in CO, IL, MI, NC, OH,TN, and WA.
RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning.  Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.
Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction  distances are used. The ROI contraction tool uses  six distances as input: right/left,  inferior/superior and posterior/anterior. These  contraction distances are, in error, pairwise  reversed, i.e. right is interpreted as left,  inferior is interpreted as superior, and posterior  is interpreted as anterior.
US Nationwide Distribution in the states of IL, VA, CO, UT, NY, FL, MA, OK, CA, TN and WY.
APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356.   Product Usage:  The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur.
The device may have improper screw hole placement due to inaccurate location of the index line.
Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia.
Offset Femoral Alignment Guide, 2mm x 6; Product Code: KS 67022   Product Usage:  The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
Offset Femoral Alignment Guide 4mm x 6; Product Code: KS 67024   Product Usage:  The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems.      Product Usage:  The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems
Nationwide Distribution including OH, RI, TX & WA.*
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.    Intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures.
Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the degradation of the plastic material of the SEDASYS System Control Unit.
Distributed in the states of AZ, CO, IA, MD, OH, PA & WA, and the countries of Australia, Canada & United Kingdom.
Wheel caster set screw for Ferno iNX Wheeled Stretcher.  Ferno iNX Wheeled Stretcher for pre-hospital patient transport.
The firm discovered an improperly installed set screw in one caster arm assembly on a unit in production. The screw assists in preventing the bearing cup on the caster assembly from backing out of the caster arm during use.
Physicians, Medical Facilities, and Prescription Specific Patients in NJ and NY
Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 9 mg/1 mg/0.1 mg/10 mcg/mL, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vials, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Doxcycline/0.9% NaCl 150 mg/150 mL IV, 150 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Tobramycin 14 mg/mL Ophthalmic Solution, 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Hydroxocobalamin (Preserved) 10,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Papervine/Phentolamine/PGE-1 Injectable, 30 mg/0.5 mg/30 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Doxycycline/0.9% NaCl 150 mg/250 mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Dexamethasone 24 mg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Morphine/0.9 % NaCl 1 mg/mL IV, 250 mL bag,  Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Glycerin (v/v) 72% Injection, 25 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Phenol 6% Injectable, 30 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Methadone 10 mg/mL Injection, 10 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Doxycycline/0.9% NaCl 300 mg/500 mL IV, 500 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Hydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Lidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ  07928.
Blood products, in which quality control and distribution/failure to quarantine units due to medical history, were distributed.
Walter Reed National Military Medical Center
Blood products, which donor screening/donor record incomplete or incorrect, were distributed.
Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes
Contain 0.1% Benzalkonium Chloride in the 5/8 bandages inside the assortment which is not listed as an active ingredient in the product label.
Product was shipped to the following states: IN, KY, MA, OH & PA.
Caesar Salad, #5.56 (2,522g) ''INGREDIENTS: Romaine Lettuce, Caesar Dressing (Soybean oil, water, distilled vinegar, Romano cheese (pasteurized part skim milk, cheese culture, salt, enzymes),*****'' *ALLERGENS** Fish, Milk, Wheat
The firm failed to declare the allergen eggs on their labels.
Kale Chicken Caesar Pasta Salad, 3.87# (1.757g) INGREDIENTS: COOKED TRI-ROTINI PASTA***CAESAR DRESSING (Soybean Oil, Water, Distilled Vinegar, Romano Cheese*** ALLERGENS: FISH, MILK, SOY, WHEAT
Kale Caesar Pasta Recovery Salad, 3.375# (1530g) INGREDIENTS: COOKED TRI-ROTINI PASTA***CAESAR DRESSING (Soybean Oil, Water, Distilled Vinegar, Romano Cheese*** ALLERGENS: FISH, MILK, WHEAT
OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01.      Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution of the eye by measurement and analysis of spherical power, cylindrical power, and cylinder axis.
Software bug was found where there was no difference in Total and Corneal high-order aberrations, but differences were found in Internal high-order aberrations.
CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life.
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA
9,696 bottles (100-count), 972 bottles (1000-count)
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Distributed in the states of CA. PA, VA, TX, MA, MD, WV, UT, FL, and TN.
0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution.
Procedures for the acceptance and control of in-process product have not been adequately established.
Distributed in Arkansas, Arizona, California, Colorado, Florida, Idaho, Kansas, Michigan, Montana, Nebraska, New Jersey, New Mexico, Oklahoma, Oregon, Pennsylvania, Texas, Utah, Washington and Wyoming.     The firm also sold directly to internet consumers on line at VeggieEvolution.com. Internet consignees are located in CA, ID, MN, MS, OR, TX, UT, VA, and WA.
Kale Crisps Zen Nori product is seaweed flavored dehydrated kale chip, sold under brand Veggie Evolution, each poly pouch has a net weight 1.5 oz.  There are six packages per case. UPC is 7 13757 57480 8.   The product's label is read in part: ''***VEGGIE EVOLUTION***KALE CRISPS***ZEN NORI***NET WT 1.5 OZ (43g)***INGREDIENTS: KALE, LEMON JUICE, UNREFINED TOASTED SESAME OIL, TAMARI, SESAME SEEDS, ONION, APPLE JUICE, GARLIC,WAKAME SEAWEED, RAISINS***ALLERGEN STATEMENT: MADE IN A FACILITY THAT USES DAIRY PRODUCTS***''.
Best if Used By dates between 071815 and 022116   The codes represent expiration dates from 07/18/2015 to 02/21/16.
Kale Crisps Zen Nori is recalled due to undeclared SOY.   Soybean is a sub-ingredient of the ingredient ''Tamari'' and soy is not declared on label.
Kale Crisps Lemon Parmesan sold under brand Veggie Evolution, each plastic package has a net weight 1.5 oz.  There are six packages per case.  UPC is 7 94504 69431 4.   The product's label is read in part: ''***VEGGIE EVOLUTION***KALE CRISPS***LEMON PARMESAN***INGREDIENTS: KALE, LEMON JUICE, EXTRA VIRGIN OLIVE OIL, PARMESAN CHEESE, FRESH GARLIC, SUNFLOWER SEEDS & SEA SALT***ALLERGEN STATEMENT: MADE IN A FACILITY THAT USES DAIRY PRODUCTS***''.
Best if Used by Date codes between 071815 and 032716.   The codes represent expiration dates from 07/18/2015 to 3/27/16.
Kale Crisps Lemon Parmesan is recalled because label declared Parmesan cheese but milk is not declared.
Vegetable Crisps Lemon Parmesan sold under brand Veggie Evolution, each poly pouch has a net weight 2 oz. There are 6 packages per case. UPC is 7 36211 15015 8.   The product's label is read in part: ''***VEGGIE EVOLUTION***VEGETABLE CRISPS***LEMON PARMESAN***INGREDIENTS: CARROTS, CABBAGE, ONIONS, LEEKS, KALE, LEMON JUICE, EXTRA VIRGIN OLIVE OIL, APPLE, PARMESAN CHEESE, GARLIC, SUNFLOWER SEEDS, SEA SALT***ALLERGEN STATEMENT: MADE IN A FACILITY THAT USES DAIRY PRODUCTS***''.
Best if Used by Date codes between 071815 and 032716.   The codes represent expiration dates from 07/18/15 and 03/27/16.
Vegetable Crisps Lemon Parmesan is recalled because label declared Parmesan cheese but milk is not declared.
Blood product, which was labeled with an incorrect expiration date, was distributed.
Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Blood product, component preparation/component not prepared in accordance with specifications, was distributed.
Vic's All Natural Original White Popcorn, Net Wt. 1-1/8 oz (32g),  UPC 46555-00062
Best By Date:  09DEC2015 Manufacture Code:  5195M75
One lot of Vic's Original White Popcorn 1-1/8oz size bags contains an undeclared milk allergen.  White Cheddar Popcorn, a product containing milk, was distributed in packaging for a different product, Original White Popcorn.
Blood product, in which donor gave history which warranted deferral or follow up and was not deferred or follow up questions was not asked, was distributed.
Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.
Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of  Argentina, Australia, Austria, Bahrain, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Jordan, Republic of Korea, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Oman, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips.
Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip stability claim of 5 days at 18-28 degrees celsius at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labeling.
Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N    Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling
Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker  causing potential skin/eye irritations
Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T    Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling.
US Nationwide Distribution in the states of  LA, SC, CA, TX, NE, VA and WV including:  Puerto Rico.
cobas b 123 Fluid Pack COOX REF 05169992001 200   Product Usage:  The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). The cobas b 123 POC system calculates derived parameters. Depending on the equipment configuration of the instrument, the Sensor Cartridge and the Fluid Pack used, the following parameters are measured in human whole blood and QC materials.
Roche Diagnostics has confirmed an issue causing low PO2 results for patient samples and QC material on the cobas b 123 POC systems.  Several customers reported QC failures of the PO2 parameter on cobas b 123 POC systems, affecting primarily Levels 1 and 2.  These QC failures are caused by a calibration issue with the PO2 parameter.  Detection of this issue is not guaranteed given QC results can be below mean values, but still within 2 standard deviations (SD) limits.  There is potential for erroneously low PO2 results in patient samples, especially in blood samples with PO2 values below 50 mmHg.
cobas b 123 Fluid Pack COOX REF 05170036001 400   Product Usage:  The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). The cobas b 123 POC system calculates derived parameters. Depending on the equipment configuration of the instrument, the Sensor Cartridge and the Fluid Pack used, the following parameters are measured in human whole blood and QC materials.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected from an ineligible donor, were distributed.
ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medicines, Inc., Irvine, CA. NDC 073-3019-11 (individual vial), NDC 0703-3019-12 (carton of five).
Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Source Plasma, collected from an inelgible donor, was distributed.
Distributed in the states of VA, PA, NY, NJ, IL, OH, and MD.
HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive.  In Vitro Diagnostic.  www.HardyDiagnostics.com
Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot.
U.S. Nationwide Distribution to the following states of:: NV, NM, TX, and MI.
Stryker Sustainability Solutions  CB5LT  Ethicon Endo-Surgery, Inc.  Excel Trocar Sleeve  w/Stability Sleeve  5mm x 100mm  Reprocessed by Stryker Sustainability Solutions    Product Usage:  The Reprocessed Ethicon ENDOPATH XCEL Universal Trocar Stability Sleeve is a sterile single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve.
Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packaging were 75mm models (CB5ST).
Blood products, which were labeled with the incorrect product type, were distributed.
Blood and Blood Products for Reprocessing
Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, GA, ID, IL, IN, KS, KY, LA, MI, MO, MS, MT, NC, NE, NM, NV, OH, OR, SC, TN, TX, UT, VA, WA, WV & WY.
Kroger Ground Cinnamon UPC 11110 70034 NEW WT. 18.3 oz Plastic container
The products were recalled because a container of Kroger Garlic Powder tested positive for Salmonella during routine FDA retail sampling. Out of an abundance of caution, the firm is recalling all items produced on the filling line between sanitation cycles.
Kroger Garlic Powder UPC 11110 70039 NEW WT 24.7 OZ Plastic Container
Kroger Black Pepper Coarse Ground UPC 11110 70041 NET WT 17.1 oz plastic container
Sell by: May 18 18PS4 & Sell by: May 19 18PS4
Kroger Bac'n Buds ARTIFICIAL BACON FLAVORED CHIPS 14.1oz plastic container UPC 0 11110 70025 4
Nationwide Distribution including NY, TX, OH, IN, FL, NH, MN, SC, OK, NJ, CA, NC, MO, GA, WI, IA, TN, WA, and Puerto Rico.
3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.
The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.
Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw System The Tiger Cannulated Screw Fixation System and the Tiger Headless Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only.
Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray.
Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and reconstructive procedures in small bones.
The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through.
Guardian Real-Time Monitor, Model No. CSS7100.  Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management.
Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a language translation error that impacts the Finnish language. Specifically, the Monitor has a Finnish translation error in Predictive Alerts setting: the on-screen Finnish translation for LOW/HIGH is reversed as HIGH/LOW.
THE ORIGINAL CHICKEN FRY MIX FROM THE MAKERS OF LOUISIANA BRAND HOT SAUCE, NET WT. 9 oz. (255g), BRUCE FOODS CORPORATION, EL PASO, TEXAS, UPC 1760002733
Products may be contaminated iwth peanut protein.
LOUISIANA CHICKEN WING SEASONING, HERBS AND SPICES, ADD FLAVOR TO CHICKEN, NET 3.0 OZ (85g), BRUCE FOODS CORPORATION, UPC 1760002153
''LOUISIANA'' WING KIT containing CHICKEN WING SEASONING, HERBS AND SPICES, ADD FLAVOR TO CHICKEN, NET 3.0 OZ (85g), BRUCE FOODS CORPORATION, UPC 1760002153 (wing seasoning)
Kit Code:  191260, Lot Code (CHICKEN WING SEASONING): 49123
Blood product, collected using a shaker device for which the quality control results were not documented, was distributed.
Becton, Dickinson and Company, BD Biosciences
US Distribution and Internationally to Taiwan.
BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809    Hematology:  The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells.
Catalog number  335809; Lot numbers 4300708, 4304864, 5013643; all with expiry dates of 31 OCT 2015
Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HLA-DR PE antibody which could result in an unexpected staining pattern.
Worldwide Distribution - US (nationwide) and Internationally to Australia, Germany and Canada.
Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
Model EIZ51, serial number range - ZRS-042132 to ZRS-042157.
Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant.
Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position.
Model EIZ4-2, serial number range - IRS-046185-IRS-063437 and IRSE-058994 to IRSE-063928.
US Nationwide Distribution in the states of TN, AZ, CT, Fl, CA, NY and WI
Dimension Vista 2-Microglobulin Flex Reagent Cartridge (B2MIC);    Product Usage:  The B2MIC method is an in vitro diagnostic test for the quantitative measurement of 2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of 2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.
Customers are receiving a high number of Abnormal Assay Errors  or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC lot 15037MA. In failure mode, there is the potential for falsely depressed beta2-Microglobulin results on the Dimension Vista system due to assay reagent contamination.
Nationwide and internationally to Canada.
Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
The end cap may loosen and detach making the instrument non-functional. No injuries reported.
Philips Electronics North  America Corporation
US Nationwide  Distribution to the states of : Arizona, Minnesota, State of Washington, Wyoming and Ohio.   Internationally to Canada.
Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1     Product Usage:  The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians.
The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal due to a defect in the Microsoft Windows 7 operating system.
Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist by: TaroPharma, Hawthorne, NY 10532. NDC: 51672-5281-7.
Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W Airport Blvd #130, Sugar Land, TX  77478, Service Code 2K2677, NDC# 61553-777-02.
Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.
EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP (4 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX  77478, Service Code 2K6244, NDC# 61553-244-61.
HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP (50 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX  77478, Service Code 2K0418, NDC# 61553-418-02.
EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP (64 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX  77478, Service Code 2K6618, NDC# 61553-618-61.
HEPARIN Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Injection USP (100 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX  77478, Service Code 2K0419, NDC# 61553-419-02.
EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX  77478, Service Code 2K6119, NDC# 61553-119-61.
The distribution spread sheet is attached via email. The firm shipped to 8 distributors and 11 retailers.
Fisher Brand chopped walnuts, packaged in 10 ounce, polyethylene stand-up bag with zipper. The bag is blue with white lettering.
A bag of Fisher Walnuts sampled by the FDA, tested positive for Salmonella.
Worldwide Distribution - US Nationwide and in the countries: Australia, Canada, Chile, China, India, Korea, Malaysia, New Zealand, Singapore, Switzerland, Taiwan and Thailand.
CARESTREAM DRX-EVOLUTION X-Ray System    Product Usage:  The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients.
Carestream became aware of an issue with its DRX Evolution System v5.7 DIRECTVIEW Software v5.6 and v5.7.  It has been determined that there is a software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph.
US Nationwide Distribution  and internationally to Canada
PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound   Product Usage:  catheter, intravascular, therapeutic, ultrasound
the catheter peel-away component hub tabs may prematurely detach. One injury reported.
Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only,  Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTICALS (USA), INC. Rochelle Park, NJ 07662, NDC 29300-128-10
Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in  the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
Worldwide Distribution-including US (nationwide) and Canada.
Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for the treatment of pediatric and adult fractures; )L) for use to provide treatment for long bone and pelvic fractures that require external fixation; and (DO) for fracture fixation (open and closed),pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphysical distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System part numbers that should be considered MR Conditional.  One serious injury reported.
Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the arm or chest through the skin into a large vein. The catheter is threaded through this vein until it reaches a large vein near the heart.
Central Venous Catheter Kit for patients >34 weeks old with the coding below were affected.    Lot Numbers:  14DB9277 and 14PB2878  Unit No: DYNDC1987A  Expiration Date: 06/2015   Serial No: N/A  UPC code: N/A
320 units for lot 14DB9277 & 320 units for lot 14PB2878
The print plate artwork for this lot was found to state:  Central Line <34 Weeks Kit  displaying an incorrect sign in front of the 34. The description for this device should have stated  Central Line >34 Weeks Kit.  The defect may lead to the product to be used on patient population that is <34 weeks rather than intended population of >34 weeks.
Worldwide Distribution - USA including the states of AL, AZ, AK, CA CO, CT, FL, GA, ID, IL IN, KY, LA, MD, MA, MI, MN, NE, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, and WI; and, the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Netherlands, Panama, Qatar, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
ExacTrac 6.0.x Patient Positioning System, Radiation therapy.    Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
Affected are ExacTrac versions 6.0.0 through 6.0.5 (v. 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5).    Serial numbers/lot numbers are not applicable for a software version.  Software revisions of the ExacTrac software have a specific software version number.     Model/catalogue numbers:  70359-01 EXACTRAC 6.0 IR POSITIONING SOFTWARE FOC  20833 EXACTRAC 6.0 IR POSITIONING SOFTWARE  20833A EXACTRAC 6.0 IR POSITIONING SOFTWARE  20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE  20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE  20833D EXACTRAC 6.0 IR POSITIONING SOFTWARE  49926 ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR)  49926A ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR)  49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR)  49927 ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR)  49927A ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR)  49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR)  49933 ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED  49933A ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED  49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED  49934 EXACTRAC UPGRADE 5.5 TO 6.0 BASIC  49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC  49996 ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY  49996A ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY  49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY  49997 ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED  49997A ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED  49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED  49928 ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR)  49928A ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR)  49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR)  49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R  49939A ET SOFTWARE UPDATE 6.0.X to 6.0.5 P&R  49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3  49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4  49936B ET SOFTWARE UPDATE 6.0.X TO 6.0.5  49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4  49938A ET SOFTWARE UPDATE 6.0.3TO 6.0.5  49973 ET DATA PREP / REVIEW SYSTEM  49973A ET DATA PREP / REVIEW SYSTEM  49973B ET DATA PREP / REVIEW SYSTEM  49998 ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT  49998A ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT  49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT
ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and  verification.
Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11,  Non sterile.   Orthopedic Manual Surgical Instrument
Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a complaint that occurred during physician training, that the guide cannot be assembled to the Salto Talaris Talar Pin Setting guide. This issue will cause the impossibility  the time of putting the Talar pin in the guide.
Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC  27597-1217.  NDC 0029-1526-11
Penicillin Cross Contamination and Presence of Foreign Substance.  Product was contaminated with penicillin and foreign substances during manufacturing process.
Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC  27597-1217.  NDC 0029-1525-44
Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC  27597-1217.
Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC  27597-1217.
Worldwide Distribution - US Nationwide and the countries Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, France, Germany, Greece, Guatemala, Hungary, India, Italy, Japan, Jordan, Korea, Lebanon, Malaysia, Mexico, Mongolia, New Zealand/Fiji, Oman, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine and United Kingdom.
LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue.   Product Usage:  The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE 3-D Assistant Visualization and provides a portable suspension system for the microscope that integrates an AC power module and microscope controls (Primary Control Panel and connectivity of foot controllers)
All units LX3 Microscope Floor Stands manufactured prior to July 2015 (Serial Numbers 1402548501X to 1502857606X)
Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports concerning loss of functionality due to issues with the cabling between the power, host and illumination modules, potentially causing the system to display a system message, and/or resulting in illumination failure.
Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH.     Intended to be used solely for lower limb prosthetic fittings.
Serial Number 201528049, manufactured on 01 July 2015
Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to issues with the resistance-control of the hydraulics, which may fail under conditions.
Worldwide Distribution - U.S. nationwide in the states of: AK, CA, CO, DE, FL, HI, ID, NY, PA, SD, TN and TX;  France, Germany, Greece, India, Israel, Malaysia, Mexico, Northern Ireland (UK), Panama, Poland, Russia, South Africa, Saudi Arabia, Switzerland, Turkey, UAE and Uruguay.
Centricity PACS-IW with Universal Viewer   Product Usage:  The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. Used in Radiology.
Model Number: Centricity PACS-IW with Universal Viewer Version 5.0 through 5.0 SP7 Codes: 2090255-001 UV 6.0 Web Client Media Kit. 05 Jun 15 to present
Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1.
Centricity Universal Viewer   Product Usage:  The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. Used in Radiology.
Model Number: Centricity Universal Viewer Version 6.0 software Codes: 2090255-001 UV 6.0 Web Client Media Kit. 05 Jun 15 to present
Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.  NDC: 43598-323-30.
Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-320-30.
Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-317-30.
Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90 Count Bottles (NDC: 43598-319-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90 Count Bottles (NDC: 43598-318-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India
Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India.
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-313-30.
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.