Grassplot Ginger Slice, NET WT. 3.5 OZ. (100g) , UPC 7246 6247, PRODUCT OF CHINA ---  Firms on label: Manufactory: Grassplot Foodstuff Factory  ADD: Huangshan Road, Huangshan Mansion, suite 417 Shantou, Guangdong, China -- Distributed by: LION PAVILION LIMITED --- Nutrition Facts: Serving Size 25 g   Servings Per Container 4 ---  The product is packaged in a clear plastic bottle.
The product contained undeclared sulfites (735 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
Blood products, collected from ineligible donors, were distributed.
Blood and Blood Products for Reprocessing
Red Blood Cells (Apheresis) Leukocytes Reduced
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
Plasma Frozen Within 24 Hours After Phlebotomy (FP24)
Platelets Pheresis Leukocytes Reduced Irradiated
Red Blood Cells Leukocytes Reduced Irradiated
Worldwide - United States Nationwide Distribution and the countries: Argentina, Belgium, Chile, Cyprus, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Netherlands, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, UAE and United Kingdom.
Breas Vivo 50 Home Care Ventilator    Product Usage:  Respiratory Care
All Vivo 50 Ventilators (215000, 215016) with firmware version 2.04
Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be registered. Accessories and monitoring equipment connected to the Vivo 50 will stop functioning as the device enters stand-by mode.
NDI Disposable Reflective Marker Spheres for Brainlab IGS system.   Product Usage:  Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient and instruments in the surgical field.
1) Catalog Number: 41773 (90 pack) All Lots beginning with the prefix C / All expiration dates; 2) Catalog Number: 41774 (270 pack) All Lots beginning with the prefix C / All expiration dates; and 3) Catalog Number: 41813 (60 pack) All Lots beginning with the prefix C / All expiration dates
Inadequate curing of adhesive, may cause the two halves of the spheres to separate.
Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, China, Colombia, Croatia, Czech Republic, Ecuador, Finland, France, Germany, Hong Kong, India, Israel, Japan, Mexico, Netherlands, Peru, Poland, Portugal, Romania, Russia, Serbia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand and United Arab Emirates.
The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part number: 66 79 847  FLOW-i Anesthesia System: Is indicated for administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.The system is intended for use in a wide range of population: from neonatal to adult patients. The system is intended for use in hospital environments, except for the MRI environment, by healthcare professionals trained in inhalation anesthesia administration. Auxiliary O2 and Suction Module: Is an option available for the FLOW-i Anesthesia System. The module contains two main parts: Flowmeter unit: The intended use of the flowmeter is to provide oxygen for patient therapy. Suction unit: The intended use is to extract body fluids from the stomach and airways.
Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the suctioning function cannot be activated or controlled by the suction unit on/off switch leading to a decrease or loss of suctioning capability of the modules.
Nationwide Distribution including FL, IL, NV, NJ, OH, and TN.
Autopen Classic Automatic insulin delivery pen, 3.0ml x 2 unit 2-42 units, AN3800, Lot 7JH, NDC 08470-3800-01,   The product is a non-sterile automatic subcutaneous injection device which delivers insulin.
The dials in the Autopens are not working - the dial does not stay dialed, but springs right back to 0.  As a result, the patient could not dial up a dose of medicine to deliver via an injection.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Tortilleria Provincia Refrigerate After Purchase White Corn Tortillas, Net Wt. 16 oz, 0 89780 10000 1 & 64 oz, 0 89780 10001 8, Tortilleria Provincia, 1200 B Clay St. Bowling Green, KY 42101 (270) 842-7733
The firm used the same label clear plastic bags with Nutrition Facts and Ingredients listed for all three type corn tortillas (Yellow, White, and Blue); the color Yellow # 2 was written in lieu of Yellow # 6 for the Blue corn tortilla; additional color ingredients (FD&C BLUE No. 1, FD&C YELLOW No. 2, FD&C RED N. 40, SODIUM BENZOATE) are included for the White and Yellow corn tortillas.
Tortilleria Provincia Refrigerate After Purchase Yellow Corn Tortillas, Net Wt. 16 oz, 0 89780 10000 1 & 64 oz, 0 89780 10001 8, Tortilleria Provincia, 1200 B Clay St. Bowling Green, KY 42101 (270) 842-7733
Tortilleria Provincia Refrigerate After Purchase Blue Corn Tortillas, Net Wt. 16 oz, 0 89780 10000 1 & 64 oz, 0 89780 10001 8, Tortilleria Provincia, 1200 B Clay St. Bowling Green, KY 42101 (270) 842-7733
Stryker Instruments Div. of Stryker Corporation
Nationwide Distribution-including the states of FL, IA, IL, IN, LA, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WI.
0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip.  Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.
Stryker Instruments is voluntarily recalling the WoundCare Replacement kits for a potential sterility breach in the packaging.
Blood products, collected from a donor whose suitability to donate was not fully documented, were distributed.
Worldwide - US Nationwide Distribution and the countries of Australia and Canada.
Inadequate curing of adhesive, which may cause the two halves of the spheres to separate.
Platelet products, collected on an instrument that failed the leukoreduction quality control process, were distributed.
Nationwide Distribution and Internationally to Canada and Switzerland.
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head,  sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when incorrectly assembled or used improperly. Precautionary statements are being added to the Reamer / Irrigator / Aspirator (RIA) Surgical Technique Guide.
Dr. Praeger's California Veggie Burgers Gluten Free 11 oz. Manufactured by Dr. Praeger's Sensible Foods Elmwood Park, NJ 07047 www.drpraegers.com Made in the USA  UPC  080868000602
Case Lot F15BC-04A  Retail Box Lot # F15BC
Dr. Praeger's Gluten Free California Burgers contain undeclared soy.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
US Nationwide Distribution in the states of: UT, CA, FL, TX, MA, GA, OK, VA, CT, OK, and WY.
Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA   Product Usage:  The Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)
Product may breach the inner and outer sterile pouches during shipping or handling.
Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20
Failed impurities/degradation specifications; two lots are out-of-specification for impurities and color
The product was distributed to Sams Club Distribution Center, located at 1325 Central Ave, University Park, IL 60484.
CapriSun Variety Pack, with a multi colored plastic wrap with white and yellow lettering, covering 4 cartons. The 4 cartons consist of fruit punch (the effected product), wild cherry, pacific cooler, and strawberry kiwi.Fruit Punch Flavored Juice Drink Blend in a blue box with white lettering and fruit pictures. The carton contains 10,6 oz pouches.
code date: 27 MAY 2016 UPC code for the case: 087684004449  UPC code for the carton of Fruit Punch Flavored Juice Drink Blend: 087684001073
1, 056 cases, 4 cartons per case, 10 pouches per carton.
Possible brass fragments in Capri Sun Fruit Punch Flavored Juice Drink Blend.
Domestic: None.   International:  Netherlands and Japan
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw.   Bone fixation screw.
Sterile packaging was not sealed.  The implantation of an unsterile screw may lead to infection.
Baked Samosa Sweet Potato (Baked Indian pastry with a savory filling), Frozen package, Net wt. 7.5 oz., No UPC
Indian pastry Baked Samosa (sweet potato) is recalled due to undeclared soy lecithin.  The firm used a pan release Canola cooking oil spray which contains soy lecithin but finished product's label does not declare soy.
Del Campo Alino Casero Seasoning Paste, 15oz; Product Code: 03138; UPC: 7 751227 000894.  Product is in a glass bottle.
Product contains undeclared preservatives, Benzoic Acid and Sorbic Acid.
Product was shipped to the following states: CA, CO, FL, GA, IL, IN, KY, LA, MD, MI, MO, NY, OH, TN, TX & WI.
Diet Bubba Cola, 20 FL. OZ (1.25 PT) 591 mL INGREDIENTS: CARBONATED WATER, HIGH FRUCTOSE CORN SYRUP, CARAMEL COLOR, PHOSPHORIC ACID, NATURAL FLAVOR, CAFFEINE. DISTRIBUTED BY: SAVE-A-LOT FOOD STORES, LTD. EARTH CITY, MO 63045 0 51933 34484 6
The firm was notified by one of it's retail stores that the ingredient statement does not declare citric acid, potassium benzoate, aspartame, and acesulfame potassium.  The product contains the label for a regular drink instead of a diet drink.
Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion.  Manual orthopedic surgical instrument.
Part Number Lot Numbers 03.037.024                       T102759
The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017).
Us Nationwide Distribution in the state ID including PR.
G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.    Product Usage:  G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.
The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of October 2015.  The correct expiration date is October 2014.
Nationwide Distribution to Florida only.
Exactech Ambassador Cervical Plate System  The Exactech Ambassador Cervical Place System is intended for anterior cervical fixation (C2-T1) for the following: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Shipped to a single consignee prior to completion of final inspection.
Exactech Single Barrel Drill Guides The Single Barrel Drill Guide is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR II, BD LSRFortessa,BD FACSAria, BD FACSAria II, BD FACSAria Ill, BD lnflux, BD FACSArray,BD Pathway 855, BD Pathway 435 and all SORP instruments.   BD Biosciences Flow cytometers for the enumeration of tissue and biological fluid samples such as blood and blood components.
Instruments installed between June 2007 and September 2011 do not contain labeling pursuant to the Food and Drug Administration's (FDA's) Guidance on Laser Products- Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50).
Nationwide Distribution including GA, CT and PA.
Etac Supporter toilet armrest Etac Supporter toilet armrests are foldable and have comfortable rounded grips for the hands. Supporter is simple to mount without the need for any tools. It fits both floor and wall mounted toilets. If space around the toilet is limited either armrest can easily be detached. Supporter includes seat ring and lid.
The Supporter toilet armrest has two Fast Nuts fixing the product to the toilet porcelain. The firm has reports of the two Fast Nuts coming loose and causing the Supporter to become unsteady.
US Distribution to the states of : CA, IL, MN, MO, OR, IL, UT RI, MA, WA, NE, NY, NJ, TX and WI.
Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1:    The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Accessories to the GYC-1000 laser were missing Laser Aperture labels.
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20;    The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Distributed in the states of FL, GA, IL, NY, TX, and WA.
Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107.   Intended to provide immobilization and stabilization of spinal segments.
Catalog Number 28202, Lot Number  AS05107
Worldwide Distribution - US Nationwide in the states of NC, IN, PA, OH and the country of the Netherlands.
Oxford Femoral Drill Guide Lateral IM Adapter    Product  Usage:   Drill guide. The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. Partial replacement of the articulating surfaces of the knee when only one side of the knee joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous partial arthroplasty in the affected compartment. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an interference with PN: 32-422822, Oxford Microplasty IM Link.
Worldwide distribution.  US states of NC and AK; Taiwan, Japan, and Germany.
ZNN Antegrade Femoral Nail (ZNN AF).  Orthopedic internal fixation device.
A single distributed ZNN Greater Trochanter Femoral Nail may have been dented.  Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure proper healing and avoid fracture malunion or nonunion.
Project 7 CARAMEL APPLE Sugar Free Gum, approximately 32 lbs. -- Manufactured by: Ford Gum and Machine Company, 18 Newton Ave., Akron, New York 14001 --- The product was supplied in cardboard bulk boxes. with a label reading, ''Project 7 CARAMEL APPLE, approximately 32 pounds Sugar Free Gum''.   Each gum piece is 1.35 g coated tablet.  Ford gum produce a raw center, which gets coated, inspected and packed into the cardboard bulk boxes.
The bulk Project 7 Caramel Apple Sugar Free Gum contains undeclared milk from a caramel ingredient used in production.
Sysco International Whole Segments Mandarin Oranges In Light Syrup Net Wt. 6 LB 10 OZ (3.01 kg) NDC: 074865629065; 6 cans per case
Product tested positive for Carbendazim.
Sour Caramel Apple Chewing, net wt .53 oz, Gum UPC 844911 002919.   Sour Caramel Apple chewing gum tablet packed in 12ct metalized PET Pouch with zipper.
Project 7  is recalling all lots of Sour Caramel Apple Chewing Gum because the caramel flavoring ingredient in the gum contains undeclared milk.
Domestic: TX NJ, NC, KY, MA, SD, MO, AL, IN, GA, AR International: Netherlands, Japan, Costa Rica
Medium Bone Plate Forceps was assembled with the incorrect grip arm tip.  Potential that the surgeon will be unable to provisionally clamp the plate to the patient's bone.
Worldwide Distribution-US (nationwide) and the countries of Australia, Austria, Belgium, Canada, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Luxembourg, Netherlands, New Zealand, Norway, Portugal, South Africa, Spain, Switzerland, and United Kingdom.
Abutment Retrieval Instrument Zirconia CC RP/WP, Article No. 37882 and Abutment Retrieval Kit, Article No. 37508 (Article No. 37882 was assembled in this kit).  Used to remove a zirconia abutment if the abutment is stuck in the implant connection due to a tight seat.  Endosseous dental implant instrument.
Nobel Biocare is recalling the Abutment Retrieval Instrument Zirconia CC RP/WP because an internal investigation showed that one dimension of the affected instrument is incorrect. Therefore this instrument cannot be used to remove the metal adapter as intended.
US Nationwide Distribution in the states of CA, MO & WI
Patient Handling System (Motion Control Software),    Product Usage:  Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
ViewRay'' received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.
US Nationwide Distribution in the states of AZ, CA, CO, FL, IL, MI, MN, NC, NJ, NV, PA, TN, TX, UT, WA and WV.
Allofix Insertion Kit, 2.0 mm, Single Drill,    Product Usage:  MTF Surgical Instruments are designed for the specific needs of the orthopedic surgeon and are intended to be used in conjunction with the associated allograft. This kit is for single use only.
Product Code: 900920, Serial #:906912041001, Expiry date 01Mar2017
Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm diameter drill.
Worldwide Distribution - US including AZ, CA, GA, ID, IL, MO, NJ, NY, NC, OR, SC, TN, WV, and Internationally to Austria, Brazil, Bulgaria, Canada, Colombia, Germany, Israel, Italy, Japan, Mexico, Russia, Taiwan, and Venezuela.
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.
Nationwide Distribution including AR CA CO CT FL GA IA IL IN KS KY LA MA MD ME MO MS NC NE NJ NY OH PA SC TX VA WA WY.
Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere'' i Influenza A & B assay, performed on the Alere'' i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in nasal swabs from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans, in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
Lot Number 0073853 (US distribution only)
Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit
Worldwide Distribution - US (nationwide) and Internationally to AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SK, AE, AR, AU, AZ, BD, BH, BR, BY, CA, CL, CN, CO, CR, DZ, EC, EG, ET, GE, GY, HK, ID, IL, IN, IQ, IR, JO, JP, KR, KW, KZ, LB, LK, LY, MA, MN, MU, MX, MY, NG, NP, NZ, OM, PA, PE, PH, PK, PR, PS, QA, RE, RU, SA, SG, SV, SY, TH, TN, TR, TT, TW, UA, VN, ZA.
Sorin  Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
Product code 16-02-80 Serial number 16S10027-16S15641
Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use.
Sorin  Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Product code 16-02-81 Serial number 16S10743-16S11708
Sorin  Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Product code 16-02-82 Serial number 16S10772-16S15523
Sorin  Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Product code 16-02-83 Serial number 16S11455-16S15190
Sorin  Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Product code 16-02-85 Serial number 16S10958-16S15634
Sorin  Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Product code 16-02-95 Serial number 16S12004-16S15385
US Distribution to the states of : NJ, VA, OH, IN, MI, FL, WI, CA, TN, MD, NC, WA, UT, ID, MO, NV and KS.
16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set.  Orthopedic manual surgical instrument.
Part Number 399.56  Lot Numbers  T106341
It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.
IMPAX Agility.   IMPAX Agility when deployed as a departmental Picture Archiving and communications system (PACS) provides an interface for the acquisition, display, digital processing, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for diagnostic purposes within the system and across computer networks.
Firm received a complaint that the hospital had sent two accession numbers over the same morning and on the Agility side the patient name was incorrect.
Vitamin Cottage Natural Food Markets, Inc.
Nationwide to Washington, Oregon, Idaho, Montana, Wyoming, Nevada, Utah, Arizona, New Mexico, Colorado, Texas, Oklahoma, Kansas, Nebraska, Missouri, Arkansas.  No foreign/govt/VA/military consignees.
Natural Grocers Caribbean Fruit & Nut Mix, Net Wt. (10 oz) (283g), packaged in plastic bag.
Vitamin Cottage Natural Food Markets, Inc is recalling one lot of Natural Grocers brand Caribbean Nut & Fruit Mix as the product contains macadamia nuts that have the potential to be contaminated with Salmonella.
Nationwide Distribution including OH, FL, IL, TX, OH, NY, AZ, and NJ.
RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD1826B5, 0FTD1826C5, UPC 690592034752. This product is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.
EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particular graphics boards with DisplayPort.
RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, UPC 690592037203. This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 690592037180. This product is intended to be used in displaying and viewing digital images those of digital mammography for review and analysis by trained medical practitioners.
0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68
Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3 x 10) Cartons.  Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217. NDC: 68084-606-21.
Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side.
HydrOXYzine Hydrochloride Tablets, USP 25 mg,  Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Nitroglycerin Transdermal System 0.2 mg/hr (10 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only,  Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-123-01
Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.
Nitroglycerin Transdermal System 0.4 mg/hr (18 cm2), For Transdermal Use Only, 30 Systems (patches) per box, Rx Only,  Manufactured for: Kremers Urban Pharmaceuticals Inc., Princeton, NJ, 08540, USA, By LTS Lohmann Therapie Systeme AG, Anderach, Federal Republic of Germany, NDC 62175-124-01
Failed Impurities/Degradation Specifications: Two lots failed specification for unknown impurity at the 24 month stability testing.
Nationwide, Puerto Rico, Guam, Canada and Singapore
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49
12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label)
Crystallization; identified as calcium salt of Ketorolac
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49
5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)