Worldwide Distribution - USA (nationwide) and the countries of : Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary,  Ireland, Italy Kazakhstan, Latvia, Liechtenstein, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland ,Turkey, Unit.Arab Emir and Vatican
ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677.   Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms.   For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.
ADVIA Centaur Homocysteine dilution recovery on the diluent identified the percent recovery for the 1:10 patient sample dilutions lower than reported in the Instructions for Use (IFU).
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Jardines 7J Queso Amarillo (Item#50100) ; label:  Jardine's 7J Ranch Queso Amarillo Cheese Dip; Mild; NET WT. 16 OZ (453g); Jardine Foods, Inc.; #1 Chisolm Trail, Buda, Texas 78610; Product of U.S.A.
Undeclared wheat due to supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.
DL Jardines Queso Loco (Item#R5230) ; Label:  Special Edition D. L. Jardine's Texas Ranch Recipes Queso Loco Cheese Salsa & Dip; Medium; NET WT. 16 OZ (453g); Jardine Foods, Inc.; #1 Chisolm Trail, Buda, Texas 78610; Product of U.S.A.
Mi Queso, Su Queso (Item#50440) ; Label:  Jardine's 7J Ranch Mi Queso, Su Queso; Medium;  NET WT. 16 OZ (453g); Jardine Foods, Inc.; #1 Chisolm Trail, Buda, Texas 78610; Product of U.S.A.
HT Traders Medium Queso (Item#HT510) ; Label:  Medium Queso; Premium Salsa; Net Wt. 16 oz. Distributed by Harris Teeter, Matthews, NC
9072 jars (or 856 cases each holding 12 jars)
Three Compadres Gift Box containing a varying combination of three Jardine products in 16 oz. glass jars.  Some Gift Boxes included one jar of either Jardine's 7J Ranch Mi Queso, Su Queso (See Product #3)  or one jar of Queso Loco Cheese Salsa & Dip (See Product #2)
Worldwide Distribution - US including the states of  CA, CO, FL, IL, NC, NJ, OH and  PA and the countries of Canada, France, Italy, Netherlands, South Africa, Switzerland, Turkey and United Kingdom.
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table.
Harmony1 models of the Harmony Bucky is incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J.
Worldwide Distribution - USA including NC, OH, CO, CA, NJ, IL, OH, PA, FL and Internationally to Canada, China, France, Italy, Netherlands, South Africa, Switzerland, Turkey, and United Kingdom.
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling electronics to indicate the presence of the grid and detector as well as detector orientation. It may be mounted to a wall stand or incorporated in a radiographic table. It is intended to be used in general radiographic applications as a component of a radiographic system.
Claymount Assemblies BV is recalling the Harmony2 model of Harmony Bucky because 1) the devices are incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J, and 2) the device's insulation values do not comply with IEC 60601-1 in all cases.
US: Nationwide (FL, IA,IN, KS, KY, ME, MO, MT, PA, TN, TX, UT, VA, WA)
LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette
Product List Number: 112410403; Lot Numbers: 280055H, 341005H
Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a Hemoset containing a burette and blood filter, intended for infusion of blood/blood products. In a gravity delivery, the correct lower lid dispenses 15 drops per mL and the incorrect lower lid found dispenses 10 drops per mL.
Lao Thai Nam Number One Sompa Salted Fish, Net Wt 7 oz. (198 g), Produced by Lao Thai Nam, 4444 W. Illinois Ave., Ste 400a, Dallas, TX 75211, UPC 8 84332 00019 4
All product distributed prior to 03/31/14.
The product has the potential to be contaminated with Clostridium botulinum.
Whole Foods Market South Seafood Distribution
Fresh Wild Gulf Amberjack (Whole, Fillet and Portion)
Firm received complaints of illness after consumption of Amberjack fish.
Yangban Rice Porridge with Abalone,  Net Wt. 10.16 oz (288 g), UPC 8 83298 61617 3, 24 cans/case
HK Galleria Wholesale is recalling Rice Porridge with Abalone because it may be contaminated with Clostridium botulinum.
Non-Mydriatic Auto Fundus Camera. Model AFC-330.  An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc.  Manufactured by Nidek Co. Ltd, Japan.
Image taken by AFC-330 has a white spot which may affect diagnosis or evaluation of image.
US Nationwide Distribution in the states of OH, NY, TX, TN, FL, CT, and VA,
The pop-off valve in the defective devices remain open and a squeeze of the bag may not generate enough force to force the duck bill valve open and therefore no air will be delivered to the victim.
Blood product, collected from a donor with polycythemia vera, was distributed.
Blood product, possibly contaminated with air during collection, was distributed.
Blood products, collected from an unsuitable donor, were distributed.
Blood product, which failed to meet the minimum specification for red blood cell percent recovery, was distributed.
Lifesouth Community Blood Centers - Montgomery Region
Blood products, for which the monthly product quality control was outside the acceptable range, were distributed.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, processed more than eight hours after collection, were distributed.
Worldwide Distribution -- USA, including the states of AK, AR, AZ, CA, CO, CT, FL, GA, GU, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, and WA; and, the countries of Australia, Brazil, Canada, China, India, Indonesia, Japan, Korea, Kuwait, Mexico, Netherlands, Pakistan, Singapore, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
Stirling Ultracold Portable Shuttle, ULT-25.   Storage for cold-chain management, short-term or long-term ultra-low and storage and transport of biological specimens.
The external power supply input is overheating at the  connection to the freezer.
Nationwide Distribution including North Carolina and Maine
Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04.    The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.
Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle
Simplexa'' Flu A/B & RSV Direct, Model Number: MOL2650.      510(k) K120413  Simplexa'' Flu A/B & RSV Direct.    The Focus Diagnostics Simplexa Flu A/B & RSV Direct assay is intended for use on the 3M Integrated Cycler instrument for the in vitro qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) RNA in nasopharyngeal swabs (NPS) from human patients with signs and symptoms of respiratory tract infection in conjunction with clinical and epidemiological risk factors. This test is intended for use as an aid in the differential diagnosis of influenza A, influenza B, and RSV viral infections in humans and is not intended to detect influenza C.
Model Number: MOL2650. All Lot Numbers.  The expiration date of the 614 kits of MOL2650 that are impacted by this Correction ranges from 10/31/2014 to 5/31/2015.
Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simplexa'' Flu A/B & RSV Direct (MOL2650). Focus Diagnostics received some customer complaints of Simplexa Flu A/B & RSV Direct assays with sporadic false signals, which may result in a higher false results rate due to a potential software spectral matrix and Direct Amplification Disc storage.
Blood product, contaminated with air was distributed.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
American National Red Cross, Penn Jersey Region
Blood product, which tested positive for Fyb red cell antigen, but was previously typed as negative for Fyb antigen, was distributed.
Blood product, collected from a donor who emigrated from a malarial endemic area, was distributed.
US Nationwide Distributions in the states of MO, GA, FL, NJ, CA, PA and including NM.
Siemens Mobilett XP Digital Mobile X-ray System    Product Usage:  The Mobilett XP and Mobilett XP Hybrid are radiographic systems designed for use in wards, intensive care, and premature birth-wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.
There is a potential fire hazard of certain Lithium-Ion batteries in the computers used in the original manufacturing or as spare parts between October 2010 and April 2011 for the Siemens Mobilett XP Digital mobile X-ray System, which might occur at any time with higher probability while the system is being charged and connected to the main power supply.
Distributed in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS.
Synthes B37 Replacement Screws.   M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026.  Surgical instrument for use with Low Bend Medial Distal Tibia Plate.  Orthopedic.
All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label.
Ocean's Catch RTE Fresh Hand Picked Crabmeat , Net WT. 6 oz. plastic container  Ingredients; Contains Jonah Crab Meat
lot number 101366 with a sell by date before 5/14/14; lot number 101507 with a sell by date before 5/20/14;  lot number 101540 with a sell by date before 5/21/14
Product contaminated with Listeria monocytogenes
Ocean's Catch RTE All Natural Jonah Crab Combo Meat Fresh Hand Picked Crabmeat , Net WT. 8 oz. and 16 oz. plastic container   Ingredients; Contains Jonah Rock Crab Meat, Salt
8oz :containers: lot number 101372 with a sell by date before 5/14/14;  lot number 101432 with a sell by date before 5/19/14;  lot number 101474 with a sell by date before 5/20/14;    16 oz containers:  ''lot number 101372 with a sell by date before 5/14/14;  ''lot number 101391 with a sell by date before 5/16/14;  ''lot number 101407 with a sell by date before 5/16/14;  ''lot number 101432 with a sell by date before 5/19/14;  ''lot number 101474 with a sell by date before 5/20/14;  ''lot number 101539 with a sell by date before 5/21/14.
Ocean's Catch  Jonah Crab Minced Meat Crabmeat , Net WT.  10 lb.  plastic bag
Nationwide Distribution: USA including states of: FL, IL, CA, CT, NC, OH, TX, WA, NH, PA, MI, IN, GA, IA, LA, MS, AZ, SC, NV, and NY.
Physique Enhancing Science ALPHAMINE, Powerful Thermogenic Powder, DIETARY SUPPLEMENT Net Wt. 8.9 oz (252 g). Raspberry Lemonade and Fruit Punch flavors.
Products contain ''Aegeline'' an unapproved New Dietary Ingredient.
Physique Enhancing Science ENHANCED, Ultra Advanced Pre-Workout, DIETARY SUPPLEMENT Net Wt. 5.22 oz (148 g).  In BlueRazz and Fruit Punch flavors
Worldwide Distribution - USA (nationwide) and the countries of Colombia, Honduras, Iran, Thailand and Uruguay.
DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure.  Used in home and clinical environments.
A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as ''RUN-TEST''.
Worldwide Distribution.  US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain.
syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B
Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.
Worldwide Distribution - USA including AL, AZ, CA, CO, FL, IA, IN, LA, MA, ME, MI, MN, NJ, NY, OH, PA, and WV. Internationally to Australia.
illumipro-10 Incubator/Reader, Meridian Bioscience, Inc.   The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions.
Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.
Blood products, collected from a donor who reported a post donation illness, were distributed.
Blood and Blood Products for Reprocessing
Distributed in the states of AK, CA, MD, MN, MO, NC, NJ, OH, and UT.
Atrium Express Dry Seal Chest Drain ATS Blood Recovery, Catalog Number: 4050-100N.   Autotransfusion Apparatus.
Product that was previously recalled because the Chest Drain tubing of the ATS Blood recovery may leak or disconnect, was released for distribution in error.
Blood product, collected from a donor whose health history was not adequately performed, was distributed.
Blood product, labeled as leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.
US Nationwide in the states WI, NC, FL, IL, TX, NC, CO, GA, and PA
Large Pitted Kalamata Olives, packaged in 4.4lb black plastic barrels. Labeling reads in part: Savor Greek Large Pitted Kalamata Olives, refrigerate after opening, these olives are mechanically pitted and may contain pit fragments, DR WT 4.4LBS (2kg)
720 cases (4 plastic barrels per case), 2,880 plastic barrels
This voluntary recall has been initiated because Savor Brands Large Pitted Kalamata Olives may contain glass.
Brunkow Cheese of Wisconsin, Monterey Jack Morel Mushroom & Onion Cheese, 5 lb block plastic wrapped and vacuum sealed.  Eight blocks per case.   Ingredients: Cultured Pasteurized Whole Milk, Salt, Microbial Enzymes, Morel Mushroom and Onion.
Brunkow Cheese of Wisconsin is recalling Monterey Jack Morel Mushroom Cheese because the product is mislabeled. The product contains other type of mushroom instead of Morel Mushrooms as listed on the label.
Rosemary & Olive Oil Gluten Free Snack Crackers sold under the following brand names and sizes:  1.  glutino, Net Wt. 4.25 oz (120g) UPC 78523-03861;  2.  glutino, 2 count 10 oz bags, Net Wt. 20 oz (566 g) UPC 78523-03863;  3.  Aldi's brand live G free, Net Wt. 4.25 oz (120g) UPC 41498-20371
Lot Code 11914 / Best ByDate 10-26-14, and  Lot Code 14314 / Best By Date 11-24-14
A seasoning supplier is recalling its rosemary and olive oil seasoning blend, which potentially may be contaminated with Salmonella.
Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1.    Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 2.    Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 3.    Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4.    Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4+.    Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 5.    Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6.    Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 7.    Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 8.     Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Alabama, Colorado, Connecticut, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Hampshire, North Dakota, New York, North Carolina, Ohio, Oklahoma, Texas, Virginia and Wisconsin
Ocean Spray Greek Yogurt Covered Craisins Dried Cranberries , 8 oz   Resealable Pouch UPC: #23719
Best By Dates: Feb 10, 2015 and Feb 11, 2015
Worldwide Distribution - US in the state of Oklahoma and in the countries of Bolivia, Chile, Germany, Japan, Korea, Taiwan, Yemen, and South Africa.
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
Software Version 02-26, when used with the Central Nursing Station (CNS) 6201, (PU-621 RA) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate.
American National Red Cross SW Region - HT
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Blood product, which failed the residual white blood cell count and labeled as leukoreduced, was distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Maui Soda & Ice Works Ltd/dba Roselani Ice Cream
Roselani Tropics Kona Mud Mud Pie Ice Cream: 1.75QT, - 56 oz.  carton.    Maui Soda & Ice Works, Ltd.  Wailuku, HI
Complaint received of a carton of  Roselani Tropics Kona Mud Pie Ice Cream that was filled with chocolate Macadamia Nut Ice Cream.
waxed paperboard int container of frozen ice cream   labeled  Thrifty Ice Cream Mint 'N' Chip  1 Pint (16 Fl. OZ.)    Bottom of container  Expiration Date: October 28 2015  Lot #24273    Back of container  UPC 1182264327
Expiration Date: October 28 2015 Lot #24273
Pistachio flavored ice cream was inadvertently packed into 16 oz. (Pint) containers labeled as Thrifty Ice Cream Mint 'N' Chip. Ingredient statement does not declare pistachio.
Ferrous Gluconate Tablets, 5gr (325 mg), Elemental Iron 36 mg, 100 Tablets, UPC 0 79854 50032 5
National Vitamin is recalling Nature's Blend Ferrous Gluconate Tablets because they are mislabeled on the front panel with 65 mg of elemental iron.  The side panel and the tablets inside the bottle have the correct label with 36mg of elemental iron per tablet.
Nationwide in US: UT, CA , AZ, NJ, MD, FL, GA, IL, TX   Worldwide to: Canada
Kirkland Signature Coarse Ground Malabar Pepper, 12.7 oz Plastic Jars, UPC 096619164998.   Packaging includes a PET bottle.  The lid is made of Polypropylene and contains a tinplate insert and a Polypropylene five-hole cap. The label on the jar is a rectangular label (front and back) information is superimposed over an antique map in various shades of brown.
Olde Thompson is recalling Kirkland Signature Coarse Ground Malabar Black Pepper because it may be contaminated with Salmonella.
Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay,  Venezuela, and Vietnam.
System Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.
Part numbers 550120 for standard; 550516 for S system and 550650 for Si System.
Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories.  Removal of the Emergency Grip Release Wrench, part number 710142.
Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System.  Intuitive Surgical Endoscopic Instrument Control System.
Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System.  Intuitive Surgical Endoscopic Instrument Control System.
Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System.  Intuitive Surgical Endoscopic Instrument Control System.
Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System.  Intuitive Surgical Endoscopic Instrument Control System.
Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System
Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System.  Intuitive Surgical Endoscopic Instrument Control System.
Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System.  Intuitive Surgical Endoscopic Instrument Control System.
Part number 551184 - US Manual; Part number 550965 - OUs manuals.
IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e.  Intuitive Surgical Endoscopic Instrument Control System
Part number 551979 - da Vinci S, Si and SI-e Part number 551980 - da Vinci Standard.
Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System .  Intuitive Surgical Endoscopic Instrument Control System
Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System.  Intuitive Surgical Endoscopic Instrument Control System.
Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System.  Intuitive Surgical Endoscopic Instrument Control System.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD) were distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
US Nationwide Distribution in the states of CA, PA, and TX
Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicondylar Knee prosthesis.
Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral.
Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.
Worldwide Distribution - USA nationwide including DC and Puerto Rico,  AUSTRIA, CANADA, GERMANY, ISRAEL, ITALY, NETHERLANDS, SPAIN, SWEDEN SWITZERLAND, and UNITED KINGDOM.
Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.
The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during contrast pressure injections. This may require an intervention to retrieve the separated piece from the patient to prevent injury.
Worldwide Distribution - US Nationwide in the states of CA, OH, RI, GA, FL, MD, NY, WV, NJ, Ma, CT, IA, NM, MN and the countries of China and Belgium.
BD FACS Canto and associated Fluidics Cart   Product Usage:  Flow cytometer for use in In vitro Diagnostics.
Laser cooling fans and internal fan of the associated fluidics cart are not operational.
Dole Garden Soup ''Roasted Garlic Tomato Basil'', Net Wt. 26 oz. (1lb 10oz) 737 g, UPC 3890002404, 6 units/case
Lot No. WF14113 and WF14114, Best By Oct 23 2015 and Oct 24 2015
Dole Packaged Foods is recalling Dole Garden Soup Roasted Garlic Tomato Basil because it contains undeclared milk.
Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and UK.
Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221
Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) Ref 3222
Lot Numbers: Lot Number 00115282   Lot Number 00115283   Lot Number 00115284   Lot Number 00115340   Lot Number 00115341   Lot Number 00115501   Lot Number 00115502   Lot Number 00115865   Lot Number 00116277   Lot Number 00116278
Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD,  ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,UT, VA, VT, WA, WI, WV, WY, and Hawaii, and the territories of Puerto Rico, US Virgin Island and Guam; and, the countries of Argentina, Australia, Austria, Belgium, Brazil, Cameroon, Canada,  Chile, Costa Rica, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Grand Cayman, Hong Kong, India, Israel, Jamaica, Japan, Korea, Lithuania, Malaysia, Mexico, Nassau, Netherlands, Nigeria, Palestine, Panama, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syria, Thailand, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Anspach Pneumatic and Electric Motor Systems.   Intended for cutting and shaping bone, including the spine and cranium.
DFU:   18-0047: Revisions A & B   18-0074: Revision A; and    18-0105: Revisions A.    Operating Manuals:   19-0010: Revisions A, and   19-0013: Revisions A, B, & C.
Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device.
Worldwide Distribution.  US including states of CA, FL, IL, MD, MO, TN, TX, and countries of Australia, Czech Republic and Spain.
MIS Rod 2, a component of the NewPort System Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm); 60-0580 (80mm).   The NewPort MIS Rod 2 is a 5.5 diameter titanium spinal rod used to immobilize adjacent NewPort pedicle screws.
Lot No.   Z21781A (45mm NewPort MIS Rod, 2)  Z21956A (50mm NewPort MIS Rod, 2)  Z21782A (55mm NewPort MIS Rod, 2)  Z21957A (60mm NewPort MIS Rod, 2)  Z21784A (75mm NewPort MIS Rod, 2)  Z21958A (80mm NewPort MIS Rod, 2)
Integra Lifesciences is recalling NewPort System MIS Rod, 2 because it may be up to 30 degrees offset from specification requirements causing misalignment with the inserter.  This could potentially result in the lordosis of the rod not aligning with the handle when the inserter is used in accordance with the current NewPort MIS System Surgical Technique.
US Nationwide  Distribution - in the states of Arizona, Florida, Kentucky, Louisiana and New Jersey.
Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE   Product Usage:  The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using the existing Triathlon Patella Resection Guide, Metal Backed Patella Drill and Patella Peg Drill Templates as per the Triathlon Tritanium Surgical Protocol.
Catalog No. 6541-3-530.  Lot Codes: CTD2778 and CTD2779.
Tritanium Patella Inserter Instrument fracture during implantation.  .
Sharp Cheddar Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 8 ounce cups with snap-on lid (14001), 14 ounce cups with snap on lid (17001), 10 lb. pail with snap on lid (12341). 2.  Central Markets in 8 oz cups with snap on lid (27056). 3. Cobblestone Market in 5 lb. pail (42403) with snap on lid. 8. Dierks Waukesha in 5 lb. pail with snap on lid (11442)
Parkers Farm is recalling  cheese and salsa products that may be contaminated with Listeria monocytogenes.  This action is being taken as a precaution in response to testing conducted by the Minnesota Department of Agriculture.
Port Wine Cold Pack Cheese sold under the following sizes and brands:  1. Parkers Farm or Parkers label in 8 ounce (14010), 14 ounce (17010), and 5 lb. (11951) white tub with snap on lid;   2. 150+Central Markets in 8 oz cups with snap on lid (27057).   3. Cobblestone Market in 5 lb. pail pails with snap on lid (42503).   4. Dierks Waukesha in 5 lb. pail with snap on lid (11952).
Olivia Swan Cheddar Cold Pack Cheese 10 lb. pail with snap on lid (12341os)
Horseradish Cold Pack Cheese sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 10 lb. pail with snap on lid (42550); 2.  Cobblestone Market in 5 lb. pail pails with snap on lid (42603).
Mild Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51305) container with snap on lid.
Hot Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51205) container with snap on lid.
Fire Roasted Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51605) container with snap on lid.
Garlic Salsa sold under the following sizes and brands: 1. Parkers Farm or Parkers label in 16 ounce (51505) container with snap on lid.
Isoniazid Tablets, USP, 300 mg, Rx only, packaged in a) 100-count bottles, NDC 0143-1261-01, b) 1000-count bottles, NDC 0143-1261-10, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ  07724; c) 30-count bottles, NDC 61748-013-30, d) 100-count bottles, NDC 61748-013-01, e) 1000-count bottles, NDC 61748-013-10, Mfd. for: VersaPharm Incorporated, Marietta, GA  30062; Mfd. by: West-ward Pharmaceutical Corp., Eatontown, NJ  07724.
a) 17,347 bottles, b) 3,015 bottles, c) 1,334 bottles, d) 5,651 bottles, e) 210 bottles
Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
Worldwide Distribution -- USA, Australia, Belgium, Canada, Croatia, Cyprus, Denmark, Egypt, Finland, France, Greece, Iran, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913.   Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.
Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914.   Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915.   Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916.   Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917.   Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.
EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display.  EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX.  Baxa Corporation.  An automated pumping system that compounds multiple sterile ingredients into a finished solution in a single patient IV administration bag.
model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX
If the universal ingredient (UI) in an active configuration is changed using the Configuration Editor, a flush of the outlet pump tube will not be initiated by the software.  It could result in the original UI remaining in the tube which could be delivered into the next bag.
Worldwide Distribution - US Nationwide and the countries of Canada, Australia, Arab Emirates, Denmark, Germany, Great Britain, India, Ireland, Israel, Japan, Kuwait, Lebanon, Malta., Netherlands, Panama, Poland, Saudi Arabia, Singapore, South Africa, Spain, Sweden, and Tunisia.
Integra LED Battery Charger, Single Bay. Product Number:  90523     The LED Headlight System Battery Charger (90523) is an accessory to the LED Headlight System:  90520US - LED Headlight w/Battery & AC/DC Power Supply - US  90520EU - LED Headlight w/Battery & AC/DC Power Supply - EU  90520UK - LED Headlight w/Battery & AC/DC Power Supply - UK  90520AU - LED Headlight w/Battery & AC/DC Power Supply - AU    Product Usage:  The Integra LED Headlight System Is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures
LED battery chargers may prematurely fail and will not charge the LED battery as intended
Worldwide Distribution-USA (nationwide) including PR and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Canada, Mexico, Argentina, Austria, Australia. Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Great Britain, Greece, Guadeloupe, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lebanon, Libya, Macedonia, Malaysia, ,Malta, Martinique, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Republic of Korea, Romania, Russian Federation, Serbia, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Sri Lanka, South Africa, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, Uruguay, and Vietnam.
ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790
The solid phase reagent in some of the ADVIA Centaur TnI -Ultra ReadyPacks, lot 084, is darker in appearance, creating a potential for incorrect control and patient results.
Worldwide Distribution-USA (nationwide) and the countries of  Algeria Argentina Brazil Canada China Chile Columbia France Indonesia Libya Georgia Germany India Italy Japan Kazakhstan Lithuania Oman Pakistan Peru Poland Portugal Republic of Korea Romania Russia Saudi Arabia Spain Turkey.
MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge. Siemens Healthcare Diagnostics, Inc. in vitro diagnostic.
WalkAway 40 - Material number: 10444853; catalog number: B1018-283; WalkAway 96 - Material number: 1044854, Catalog number B1018-284.
WA40: 560  US, 131 OUS, 9 already repaired; WA96: 81 US, 189 OUS, 57 repaired.
Springs contained in the access door hinge assembly on the Walk Away Plus instruments are becoming detached causing premature failure of the hinge assembly and a potential safety issue for the customers.
Worldwide Distribution - USA including PR. DC, GUAM, all states except VT.  Internationally to the following countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BENIN, BOSNIA AND HERZEGOVINA, BOTSWANA, BRAZIL, BULGARIA, BURKINA FASO, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH  POLYNESIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HONG KONG, HUNGRY, ICELAND, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMHIRIYA, LITHUANIA, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, PAKISTAN, PANAMA, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TUNISIA, TURKEY, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM YEMEN.
GE Healthcare, Proteus XR/a.   Proteus XR/a Intended Use: Is intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
GE Healthcare has become aware of a potential safety issue due to a collimator installation error during a service maintenance activity involving the Proteus XR/a and Revolution XR/d X-ray imaging systems. .    There was a reported incident of a collimator fall which caused a serious patient injury.
GE Healthcare,  Revolution XR/d.   Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Worldwide Distribution - USA including CA, MO, VA, PA, WV, and Internationally to Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, France, Germany, Greece, India, Iraq, Israel, Italy, Japan, Kazakhstan, Malaysia, Mexico, Morocco, Netherlands, Norway, P.R. China, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., Ukraine, United Kingdom.
ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.
There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.
Bystolic (nebivolol) tablets, 20 mg/tablet. 7 Tablet Professional Sample Bottle, Rx Only.  Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, Missouri 63045. NDC 0456-1420-07.
Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.
Laceration Trays, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc., Arden, NC.
474 cs (9,480 ea) total for all kits involved.
Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
Laceration/Suture Removal, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Model number: 72347, Lot number: 187172, Exp. Date: 9/1/2015.
474 cs (9,480 ea) total for all kits involved
Suture Set, Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Model number: 58468B, Lot number: 187203, Exp. Date: 11/1/2016.
Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Model number: 58647B, Lot number: 187175, Exp. Date: 12/1/2015.
Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Model number: 70828, Lot number: 187176, Exp. Date: 1/1/2016.
Safety Laceration Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Model number: 59108B, Lot number: 187210, Exp. Date: 2/1/2017.
McKesson Medi-Pak, Laceration Trays with Cotton O.R. Towels, Sterile, Single Use, Latex Free, 20 Each per Case, Rx only, Distributed by: McKesson Medical Surgical, Inc., Richmond, VA 23228
Laceration Kit: W/Needles, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Model number: 68718, Lot number: 187198, Exp. Date: 12/1/2016.
Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500 mg/250 mL (10 mg/mL), 250 mL Single Use IntraVia container, packaged in 10 x 250 mL Single Use IntraVia containers per carton, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61.
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Worldwide Distribution: US Nationwide, Canada, Australia, Barbados, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Great Britain, Greece, India, Italy, Japan, Jordan, Malaysia, Netherlands, Peru, Russia, Singapore, South Africa, Spain, Taiwan, Turkey, and United Arab Emirates.
Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory.   Model numbers:    PP-5.75-90  PP-9-90  PP-5.75-90PL  PP-9-90PL
CODE: Model #s: PP-5.75-90, PP-9-90, PP-5.75-90PL, PP-9-90PL.  Lots with labeled expiry date of May 2, 2015, or later.
Total number of Boxes Distributed 32,760.  US 4,093 / Canada 1,156 / EU & Other 27,511
Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration
The firm distributed to one firm in Indiana
There is no code information.  The package shows the type of mice and the quantity.
The firm imitated a voluntary recall of frozen mice intended for use as reptile feed because of possible human exposure to Lymphocytic Choriomeningitis Virus from handling the mice.
Brookfield Prescription Center Inc. dba MD Custom Rx
Mometasone 0.6 mg /60 mL Irrigation solution, 4000 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI  53045
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Diphenhydramine (Alcohol Base) 25 mg / 0.5 mL Solution, 30 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI  53045
HCG (Human Chorionic Gonadotropin) 125 units/ 0.1 mL drop, 5 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI  53045
HCG 125U/Tab Tablet Tritu, 50 tablets per bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI  53045
HCG (Human Chorionic Gonadotropin) 200 units/ 0.1 mL drops, packaged in 5 mL and 10 mL bottles, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI  53045
HCG (Human Chorionic Gonadotropin) + Methylcobalamin (Methyl B12), 1500 units  + 1000 mcg/mL drop, 8 mL bottle, Rx only, MD Custom Rx, 19035 W. Capitol Dr., Ste. 105, Brookfield, WI  53045
Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India. 30-Count Bottle NDC: 41616-758-83,  90-Count Bottle: NDC 41616-758-81.
30 Count Bottle: Lot #: JKL5054A, Expiry: 08/2014; Lot #: JKM2305A, Expiry: 03/2015.  90 Count Bottle: Lot #: JKL5054B, Expiry: 08/2014; Lot #: JKM2305B, Expiry: 03/2015.
26,530 30-Count Bottles; 14,597 90-Count Bottles
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Distributed in the states of AR, TN MO, KS, TX, MS, and AL.
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.
the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. The upper paper layer may serve as a protective barrier and help support overall packaging.
Worldwide Distribution - USA including the states of : AZ, CA, CO, DC, FL, GA, IL, MA, MD, MN, MO, MS, MT, NC, NJ, NY,OH, OK, OR, PA, TX, VT, WA,WI. Government Facilities: AZ, CA, CO, FL, HI, IA, KY, MA, MN, MO, NC, ND, NE, NV, OH, OK, SD, TX, and WV. and the countries of : Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada,  Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Indonesia, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and UK.
BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat Panel Detector (FPD): product code 882454.  Gamma camera for Single Photon Emission Computed Tomography (SPECT). Medical Device for imaging.
Flat Panel Display (FPD) failed to remain securely locked in the deployed position.