Philips Electronics North  America Corporation
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Gibraltar, Great Britain, Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Martinique, Mayanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Republic of Korea, Reunion, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, State of  Palestine, Sweden, Switzerland, Taiwan, Thailand, Tanzania, Tunisia, Turkey, United Arab Emirates, Uzbekstan and Vietnam.
Philips Healthcare Brilliance 64 Computed Tomography X-ray system
During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
Philips Healthcare Ingenuity Core Computed Tomography X-ray system
Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
Philips Healthcare Ingenuity CT Computed Tomography X-ray system
Del Pasado Dice Green Chiles 100% Fire Roasted and Peeled NET WT. 6 LB 3 OZ (2.81 kg) packaged in #10 steel cans
USA:  CA, CO, FL, GA, IL, IN MD, MA, MI, MN, MO, NJ, NY, NC, OH, PA, SC, TX, WI.
Sprinkle King, Lime Green Sanding Sugar, 30611201.00N, UPC #30763089281012, NET WT: 150 lb (68.182 kg)
Sprinkle King,  White Coarse Sugar, 30621693.L32,  UPC: Outer: 30763089281623 / Inner: 763089280601,   ,NET WT: 32 lb (14.51 kg).    DDA, WHITE CON AA DDA (Coarse White Sugar) , Q31320.L32, 01064873, 01064823 (net wt 8 lb), UPC: Outer: 29519151867 / Inner: 29519151850, NET WT 32 LB (14.51 kg).     Sprinkle King, 40#MTO WHITE SUGAR GEMS (Coarse White Sugar), Q32322.440, UPS 1076618323225, NET WT 40 lb (18.14 kg).      Sprinkle King,  WHITE CON AA SUGAR  (Coarse White Sugar), QWHI533.440  , UPS Outer: 10766818323119,  NET WT 40 lb (18.14 kg).      Bake Sense,  WHITE CON AA SUGAR  (Coarse White Sugar), 52274, QWHI513.01, UPS Inner: 10018609922743; Outer: 18609522748  ,  NET WT 32 lb (14.5kg).
Sprinkle King,  Green Sanding Sugar, Q35111.G32,,  UPC: 10766818350023, NET WT: 320 lb (144.3 kg).    Sprinkle King,  Green Sanding Sugar, QGRN413.L32,   UPC: 10766818311109/  00766818311102, , NET WT: 32 lb (14.51kg).    Sprinkle King,  Green Sanding Sugar, QGRN433.440,    UPC: 10766818321122 , NET WT: 40 lb (18.14 kg).
Sprinkle King,  Black Sanding Sugar, QBLK413.L32,  UPC: Inner: 00766818310006 ; Outer: 10766818310003,    NET WT: 32 lb (14.51 kg).
Sprinkle King,  Blue Sanding Sugar, QBLU413.L32, ,  UPC:Inner: 00766818310303 ; Outer: 10766818310300,   NET WT: 32 lb (14.51 kg).
Sprinkle King, Red Sanding Sugar,QRED413.L32,     UPC:inner 766818312604; outer 10766818312601  ,  NET WT: 32 lb (14.51 kg).    Sprinkle King, Red Sanding Sugar, QRED433.440,      UPC: 10766818322655,  NET WT: 40 lb (18.14 kg).      Sprinkle King, Red Sugar,QRED443.00N,       UPC: 10766818342615,  NET WT: 150  lb (68.182 kg).
Bake Sense, White  Sanding Sugar,m QWHI413.01, 52273, 92273 ( net wt 8 lb),  UPC: inner 92273; outer 10018609922736, ,  NET WT: 32 lb (14.51 kg).   Sprinkle King, White Sanding Sugar,QWHI413.L32,      UPC:inner 766818313106, outer 10766818313103,  NET WT: 32 lb (14.51 kg).
Sprinkle King, Yellow Sanding Sugar,QYEL413.L32,     UPC:Inner: 766818313403; Outer: 10766818313400,  NET WT: 32 lb (14.51 kg).
US including CA, CO, FL, IA, IL, KS, LA, MD, MN, MO, NC, TN and WA and Internationally to Asian Pacific, EU, Latin America, and Japan.
Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU,   ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT.  Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.
Model Number: ED-200XU: Serial Numbers: 6572042, 5511033 and H451107   Model Number: ED-200XT: Serial Number: 8681034    Model Number: ED-250XT: Serial Number: HD077A008    Model Number: ED-310XU: Serial Number: 8591013    Model Number: ED-420XL: Serial Numbers: 9711002, 2D071D016, 2D071D010, 2D071D029 and 2D071D026    Model Number: ED-410XT: Serial Numbers: 8691039, 8691034 and 7691022    Model Number: ED-410XU: Serial Numbers: 2D060D010, 2D060D003, 6602091 and 6602100    Model Number: ED-450XL: Serial Numbers: 6D075B023, 6D075B015, 1D075B029 and 6D075B020    Model Number: ED-450XT: Serial Numbers; 1D076A002, 1D076A011, 1D076A013, 1D076A043, 1D076A039, 6D076A020, 6D076A033, 6D076A039, 6D076A037, 6D076A030 and 6D076A051
79 units (US) and 985 units (Internationally)
A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
HCC Basil Pesto FS and S; Houston Culinary Center Basil Pesto
Use of ingredient with violative pesticide residue.
HEB Shrimp Salad SS and FS By Lb; HEB Shrimp Salad 8 oz
HEB Herb Seared Salmon Herb SS and FS; Houston Culinary Center Herb Seared Salmon
Asian Salmon with potato and green beans
Pizza artichoke chicken 12 in Hot and Cold
HEB Herb Seared Salmon, Broccoli, Rice SS
Houston Culinary Center Yellowfin Tuna Salad Kit
Houston Culinary Center Greek Pasta Salad Kit
Houston Culinary Center Cranberry Turkey Salad Base
Houston Culinary Center Shrimp Salad Kit
Houston Culinary Center Penne Mozzarella Salad Kit
AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack,  8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only.   Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.
Summit Medical is recalling Doyle P/F Nasal Pack w/Airway, string 8 cm x 3 cm x 1.5 cm, Catalog # RH-7413-10, Lot # 160889 & 161354 because the product does not have the split in the packing.
Internationally Distribution only to the countries of :  Australia, Austria, Belgium, Chile, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, India, Ireland, Italy, Japan, Kenya, Luxembourg, Namibia, Netherlands, Norway, Slovenia, South Africa, Spain, Sweden, Switzerland, United Kingdom.
MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710   The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes meltitus in persons requiring insulin. In addition, the pump system is indicated for continuous monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes
Medtronic MiniMed is recalling the MiniMed 620G insulin pumps because they may experience a malfunction which would result in a pump error message. Medtronic has identified the potential reason for these motor failures as either lack of greasing or deficient greasing in a ball bearing assembly of the motor.
MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712   The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes meltitus in persons requiring insulin. In addition, the pump system is indicated for continuous monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes.
Medtronic MiniMed is recalling the MiniMed 640G insulin pumps because they may experience a malfunction which would result in a pump error message.
Heng Cheong Loong Co., Net Wt: 10 oz. (5g), Plastic Bag, Product of U.S.A, UPC 6-930481-211418
Tristar Food Wholesale Co. Inc. is recalling Heng Cheong Loong Co. Golden Raisins because it contains undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life threatening allergic reactions if they consume this product.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
GORGEOUS MEMORY brand Daylily, NET WT: 10.6 oz. (300 g), UPC 6 932960 968806, Product of China --- MINHANG FOOD CO., LTD, 103 Eldridge St., New York City, NY 10002 --- Nutrition Facts: Serving Size: 1 tbsp (100g), Servings Per Container: 4
The product contained undeclared sulfites (44779 ppm) based on sampling and analysis by New York State Department of Agriculture and Markets.
Curry Chicken Salad, Our Chefs Own, sold by weight  UPC Code : 285551
Product contaminated with Listeria monocytogenes
Curry Chicken Salad Wrap, Made Right Here, sold by weight, 12oz  UPC  263144  UPC Code : 285551
Single Curry Chicken Salad Wrap, Made Right Here, 7oz UPC 263126
Curry Chicken Salad CC, sold by weight  UPC  261068
PPK Salad Chicken Curry, sold by weight UPC  263142
Curry Chicken Salad Rollup, 7oz UPC  265325
Classic Deli Pasta Salad, Sold by weight  UPC  260976
FP Pasta Salad Classic Deli, sold by weight  UPC   270742
Classic Deli Pasta Salad, 6oz  UPC   0 36406 30001 7
Classic Deli Pasta Salad, 14 oz  UPC   0 36406 30264 6
Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated
Apheresis blood products, incorrectly labeled as having an extended expiration date, were distributed.
Nationwide Distribution including IL, GA, FL, NC, CA, AL, MA, IN, MO, NY, TX, VA, KS, and IA.  Product was also distributed to Puerto Rico.
Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge.      Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
Antibiotic concentration may be insufficient which may result in incorrect test results.
Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis product, for which the residual white blood cell count testing did not meet specifications, was distributed.
Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
OmniPod, Insulin Management System (US) Catalog Number: PODZXP420    Product Usage:  The OmnniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
OmniPod, Insulin Management System (OUS) Catalog Number: 14810     Product Usage:  The OmnniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
Blood product, which did not meet the acceptable product specifications, was distributed.
Blood products, collected from a donor who was previously deferred, were distributed.
Blood and Blood Products for Reprocessing
United States: CT, FL, IL, IN, MI, NH, NJ, NY PA, VT and WI.  Product also distributed to Canada.
Metro Irresistibles Gluten Free Cheese Ravioli 6- 9 ounce bags Use By 020317; Imported for Metro Brands, Montreal Quebec, H1C 1V6, Toronto (Ontario) M9B 1B9 UPC 059749935609
6 - 9 ounce bags per case; Use By 020317
This recall has been initiated due to possible contamination with Salmonella which was found in a raw product by a third party laboratory.
Metro Brand Irresistibles Gluten Free Cheese Ravioli with Marinara Sauce Microwave Meal 340 g Use By 020317; Imported for Metro Brands, Montreal Quebec, H1C 1V6, Toronto (Ontario) M9B 1B9 UPC 059749935609
6 - 340 g (12 ounce) meals per case; Use By 021117
Conte's Gluten Free Wheat Free Cheese Ravioli Net Wt. 12 Ounces Conte's Pasta Co. Inc. 310 Wheat Road, Vineland, NJ  08360 800.211.6607 www.contespasta.com UPC 734158940092
6 - 12 ounce bags per case; Use By 020317
Conte's Gluten Free Wheat Free Cheese Ravioli With Marinara Sauce Net Wt. 12 Ounces Conte's Pasta Co. Inc. 310 Wheat Road, Vineland, NJ  08360 800.211.6607 www.contespasta.com UPC 734158944458
6 - 12 ounce meals per case; Use By 02052017 and 02112017.
Conte's Gluten Free Wheat Free Cheese Ravioli With Marinara Sauce (French Labeling - Raviolis Au Fromage avec sauce Marinara) Net Wt.  340 g (12 Ounces) Conte's Pasta Co. Inc. 310 Wheat Road, Vineland, NJ  08360 800.211.6607 www.contespasta.com UPC 734153944458
6 - 12 ounce bags per case; Use By 02112017
Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, and New Zealand.
Alaris Pump SmartSite Infusion Set, Model No. 2420-0500.   Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
CareFusion is recalling the Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion.
Specialty Commodities, Inc. is recalling a specific lot of Flax Meal that may be contaminated with Salmonella typhimurium.
Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICAL INDUSTRIES LTD Jerusalem, 971010 Israel, Manufactured for: TEVA PHARMACEUTICAL INDUSTRIES USA Sellersville, PA 18960. NDC 0093-8238-98
Labeling: Incorrect or Missing Lot AND/OR Exp Date.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Apheresis Platelets, Leukocytes Reduced, Irradiated
Blood product, with incomplete documentation of the irradiation process, was distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Nationwide Distribution including AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MI, NJ, NY, NV, OK, PA, TX and UT.
Unolok Blunt Fill Needle 18G x 1.5'' Red, Sterile, Single use, Non-injectable needle,   Single use, non-injection needle
Particulates: Complaints of rubber coring from the closure of injection vials.
Blood products, leukodepleted greater than three days after collection, were distributed.
Worldwide Distribution - US (nationwide) and Internationally to Germany, Bulgaria, Puerto Rico, Greece, Lebanon, Italy, Philippines, Panama, Spain, Republic of Serbia, Saudi Arabia, China, South Africa, Kuwait, Morocco, U.A.E., Turkey, Georgia, Bermuda, Indonesia, Israel, Czech Republic, France, Canada, Brunei Darussalam, and South Africa.
GlideScope Video Laryngoscope (GVL), Part Number GVL 3 - 0574-0007; GVL 4 - 0574-0001; GVL 5- 0574-0030. The system consists of a video laryngoscope and portable video monitor. The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical procedures.    GVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor.
total 540 units (380 units in the US and 160 units outside the US)
Verathon has become aware that certain models and serial numbers of GlideScope GVL and AVL laryngoscope blades may separate as a result of insufficient process controls and monitoring, potentially resulting in inadequate bonding of the silicone adhesive affixing the halves of the blade. The potential for blade separation may not be readily visible during routine inspection before or after intubation.
GlideScope AVL Video Laryngoscope (AVL), Part Number AVL 3- 0574-0115; AVL 4-0574-0116, AVL 5- 0574-0117.   AVL is a video laryngoscope that incorporates a high resolution color camera, an LED light source and video output to a remote monitor.  This system has a digital platform.
425 units (171 units in US and 254 units outside US)
Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and countries of: Foreign accounts:  Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Japan, Korea, Netherlands, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, Angola, Puerto Rico, Republic of Belarus, Republic of Belarus, Benin, Bosnia, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Chad, Democratic Republic of Congo, Costa Rica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Gabon, Guam, Guatemala, Guatemala, Guinea, Honduras, Indonesia, Iraq, Israel, Ivory Coast, Kazakhstan, Kenya, Kenya, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malaysia, Mali, Portugal, Myanmar, Managua, Niger, Nigeria, Palestine, Philippines, Philippines, Qatar, Kingdom of Saudi Arabia, Senegal, Serbia, Slovakia, Togo, Tunisia, Ukraine, UAE, Vietnam, Vietnam, Ivory Coast and Zimbabwe.
MYLA CLINIC PATCH 3.2.0 CD   Product Usage:  MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
REF # 414518, Serial number/Software version V3.2 CLI
MYLA software connected to a Laboratory Information System (LIS) and a VITEK 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.
MYLA MASTER DVD 3.2 CLI DL380   Product Usage:  MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
REF # 415358, Serial number/Software version V3.2 CLI
MYLA CLINIC PATCH 3.3.0 CD   Product Usage:  MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
REF # 416192, Serial number/Software version V3.3 CLI
MYLA MASTER DVD V4.0 CLI   Product Usage:  MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
REF # 416546, Serial number/Software version V4.0 CLI
MYLA MASTER DVD V4.1 CLI   Product Usage:  MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
REF # 417191, Serial number/Software version V4.1 CLI
MYLA CLI V3.X TO V4.1 DL380 SERVER   Product Usage:  MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
REF # 419071, Serial number/Software version V4.1 CLI
MYLA CLI V3.X TO V4.1 ML350 SERVER   Product Usage:  MYLA is a computer application (Middleware) based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s)).
REF # 419072, Serial number/Software version V4.1 CLI
219772 509998 MARKET DISTRICT APRICOT LOG
219772 509998 MARKET DISTRICT APRICOT LOG Sell by dates 11/7/15 through 11/17/15 (5 day shelf life, started selling 11/2/15 pulled 11/12/2015)
All lots of Market District brand Apricot Logs and Poppyseed Logs prepared and sold individually from the Bakery department inside Giant Eagle and Market District supermarkets with sell by dates from November 7, 2015 through November 17, 2015 have been voluntarily recalled by Giant Eagle due to an undeclared milk allergen
219773 509997 MARKET DISTRICT POPPYSEED LOG
219773 509997 MARKET DISTRICT POPPYSEED LOG Sell by dates 11/7/15 through 11/17/15 (5 day shelf life, started selling 11/2/15 pulled 11/12/2015)
Worldwide Distribution: US (nationwide) and country of: Canada.
Flexible Screw Driver SJ706R;  Non Sterile;    B Braun;   Aesculap;   Aesculap AG     These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
The flexible shaft of the instruments may break during surgery.  To date there have been 18 reports of breakages during surgery.  There is a risk of a delay in surgery or that a fragment from the shaft could be left in a patient.
Flexible Bone Awl;  SJ607R; NON STERILE;   B Braun  Aesculap;   Aesculap AG:     These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
Flexible Drill;  SJ723R; NON STERILE;   B Braun  Aesculap;   Aesculap AG    These instruments are intended for use during the implantations of the A-Space SIBD and Arcadius XP L systems.
US Distribution -- To the states of WI, PA, OH, ME, IL, and NY.
Perseus A500 Anesthesia Workstation, MK06000.   Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. The device power switch may spontaneously fail during use, causing one of the following to occur: 1. The workstation has a fresh gas delivery failure and a ventilator failure with respective alarms. 2. The workstation shuts down completely with an audible alarm.
Honey Mustard Pretzel Mix sold under the following brand and size:  Girl Scouts, NET WT 7 oz. (198g).
No code on packaging but consumers would have received affected product on or before November 15, 2015.
The honey mustard pretzel mix lists whey in the ingredient list but does not list Milk in the Contains statement.
Honey Mustard Mix sold under the following brand: Ashdon Farms, Net Wt. 8 oz. (227 g), UPC 79113-41184
The honey mustard mix lists whey in the ingredient list but does not list Milk in the Contains statement.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Catalog No. INF0020-A  EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector (spiked set); Catalog No. INF0500-A - 500ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No INF1200-A - 1200ml EnteraLite Infinity Enteral Pump Delivery Set with ENFit Connector System and Transitional Stepped Connector; Catalog No GR1200-A  1200ml Enteral Feeding Delivery Set with ENFit Connector System and Transitional Stepped Connector (gravity set).   Used to dispense liquid nutrients at a preprogrammed pump or user controlled rate.
All EnteraLite Infinity Enteral Pump Delivery Sets with ENFit connector System and transitional Stepped Connector.
Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.
US Nationwide Distribution and the country of Canada.
Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, Life Brand, Target, Top Care, Best Choice, Western Family. Device is packaged in plastic blister with cardboard insert, 2 AAA batteries installed, a Quick Start Guide, and an Instruction Manual booklet.   Product Usage:  Device is a handheld thermometer that employs a thermistor sensor intended for people to take a human body temperature at the temporal artery location, the area between the outer corner of the eye and the hairline directly over the temporal artery.
Model KD-2201. all lots produced during the 36th week of year 2012 (09/03-07/2012) through and including the 37th week of year 2015 (09/07-13/2015). Lot No. S/N: 3612 through S/N: 3715''
Bestmed is initiating a field action for Digital Temple Thermometer (DTT) Bestmed is initiating a field action for Digital Temple Thermometer (DTT) due to an incorrect calibration of the thermometer that causes the device to display inaccurate and frequently lower temperatures than the actual body temperature of the user.
Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devices.
Avocado Leaves (Hoja De Aguacate), Net Wt. 10lbs
Santa Maura Spice & Garlic is recalling avocado leaves (hoja de aguacate) because it may be contaminated with Salmonella.
Distributed in Tennessee, Florida, Michigan, and Pennsylvania and in Saudi Arabia.
VentriClear II Ventricular Drainage Catheter Set.  Allows external access and drainage of cerebrospinal fluid (CSF) from the ventricles of the brain.
Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage Catheter Set due to the device being sterilized twice, which may result in the minocycline and rifampin catheter coating to be less than what is indicated on the labeling.
Nationwide Distribution -- AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, & Puerto Rico.
MOSAIQ Oncology Information System.   Used to manage workflows for treatment planning and delivery.
First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-allergy and duplicate drug therapy interaction checking.
US Distribution to the states of : AL, AZ, CA, GA, IL, KY, LA, MA, MI, MN, NJ, NY, NC, OH, OK, OR, PA, TN, TX and WA.
Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column
Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed.
Blood products, in which donor screening/deferral screening not done or incorrectly performed, including incorrect ID used during search, were distributed.
Worldwide Distribution - US Nationwide in the states of: AR, AZ, DC, FL, GA, IL, IN, LA, MI, NC, NE, NJ, NV, NY, OH, SC, TN, TX, WA. and the countries of Algeria, Bangladesh, Bosnia and Herzegovina, Brazil, China, Dominican Republic, Ethiopia, Georgia, Germany, India, Indonesia, Italy, Lebanon Martinique , Morocco, Poland, Republic of Moldova, Russia, Spain  Thailand, Trinidad, Turkey, and Uzbekistan.
GE Healthcare Optima CL323i    Product Usage:  The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems .
GE Healthcare Optima IGS 320.   Product Usage:  The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures. Additionally, with the OR table, the angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for image-guided surgical procedures. The OR table is suitable for interventional and surgical procedures.
GE Healthcare has recently become aware of a potential safety issue related to a non-recoverable loss of displayed imaging (loss of monitor video) involving Optima CL323i & Optima IGS 320 systems.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
American Red Cross Blood Services Northern NewEngland Region
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Untested Source plasma for further manufacture was distributed.
Untested Source Plasma for further manufacture was distributed.
Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Columbia, Croatia, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Norway, Oman, Panama Philippines, Poland, Portugal, Puerto Rico , Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay, and Vietnam.
UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, B24802 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a benchtop or with a floor stand. The DxH 600 is available as an analyzer for use on a benchtop only.
all serial numbers Part Nos. 629029, B24465, B24802
Beckman Coulter is recalling the DxH 800 Slidemaker Stainer Software version 3.0.2.0 and DxH 600 software version 1.1.1.0 because the software for the DxH systems allows the creation of multiple orders with the same Specimen identification (ID) but different Patient identification when manually editing pending orders at the System Manager.
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniCel DxH 800/DxH 600 analyzers are quantitative, multi-parameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a benchtop or with a floor stand. The DxH 600 is available as an analyzer for use on a benchtop only.
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.
Stryker Instruments Div. of Stryker Corporation
Nationwide Distribution including PA and SC.
Cournand Modified 2-PC 19G, 5.4cm or (Guidewire Introducer Needle) 20 units per case  The Stryker Guidewire Introducer Needles are designed for the percutaneous puncture of the anterior/posterior wall of a blood vessel. This provides an entry for a guidewire, vessel dilator, sheath, and catheter introduction.
Model Number(s): 0910-192-000  Lot Numbers Affected  61406007  expiration date:  8/31/2015
The Guidewire Introducer Needle (0910-192-000) was shipped after the documented expiration date or with minimal time until expiration. There is a potential risk of a soft tissue infection to the patient if device is used after expiration date.
W071215042535 (triple collection); W071215042353 (triple collection);
Apheresis products, for which quality control testing for pH as part of a process validation was not performed, were distributed.
American National Red Cross Southeastern Michigan Region