Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Nelson's Dutch Farms; Bullwinkle; Half Gallon; Nelson's Ice Cream, Inc., Royersford, PA 19468.    Nelson's Dutch Farm; Bullwinkle; Nelson's Creamery, LLC, Royersford, PA 19468; One Pint.    Merrymead Farm Market Premium Ice Cream; Bullwinkle; Half Gallon; Dist. by Merrymead Farm Market, 2222 Valley Forge Road, Lansdale, PA.
Dutch Farms HG - 2233 units; DF Pint - 400 units; Merrymead - 64 units
The firm is recalling Bullwinkle ice cream products as product labels failed to declare Soy (from soy lecithin) as ingredients.
Nelson's Dutch Farms; Cappuccino Crunch; Half Gallon; Nelson's Ice Cream, Inc., Royersford, PA 19468.    Merrymead Farm Market Premium Ice Cream; Cappuccino Crunch; Half Gallon; Merrymead Farm Market; 2222 Valley Forge Road, Lansdale, PA.
The firm is recalling Cappuccino ice cream as product labels failed to declare the allergen Soy (from soy lecithin) as an ingredient.
Nelson's Dutch Farms; Coconut Almond Joy; Half Gallon; Nelson's Ice Cream, Inc., Royersford, PA 19468.      Merrymead Farm market Premium Ice Cream; Coconut Almond Joy; Half Gallon; Merrymead Farm Market, 2222 Valley Forge Road, Lansdale, PA.
The firm is recalling Coconut Almond Joy ice cream products as product labels failed to declare the allergens wheat and Soy (from soy lecithin) as ingredients.
Nelson's Dutch Farms, Chocolate Bullwinkle; Half Gallon; Nelson's Ice Cream Inc., Royersford, PA 19468;      Merrymead Farm Market Premium Ice Cream; Chocolate Bullwinkle; Half Gallon; Merrymead Farm Market, 2222 Valley Forge Road, Lansdale, PA.
The firm is recalling Chocolate Bullwinkle ice cream products as product labels failed to declare the soy allergen (from soy lecithin) as ingredient.
Nelson's Dutch Farms; Vanilla Fudge; Half Gallon; Nelson's Ice Cream Inc., Royersford, PA 19468;      Nelson's Dutch Farms; Vanilla Fudge; One Pint; Nelson's Creamery, Inc., Royersford, PA 19468.    Merrymead Farm market; Vanilla Fudge; Half Gallon; Merrymead Farm Market, 2222 Valley Forge Road, Lansdale, PA.     Heritage's Old Fashioned Premium Ice Cream; Half Gallon;  Heritage's Dairy Stores, Thorofare, NJ 08086;  Vanilla Fudge.
DF HG - 481 units.; DF Pints - 456 units,Heritage - 80 units; MM - 22 units.
The firm is recalling Vanilla Fudge ice cream products as product labels failed to declare the Soy allergen (from soy lecithin) as ingredient.
Nelson's Dutch Farms; Chocolate Chip Cookie Dough; Half Gallon; Nelson's Ice Cream, Inc.,  Royersford, PA 19468.     Nelson's Dutch Farms; Chocolate Chip Cookie Dough; One Pint; Nelson's Creamery, LLC; Royersford, PA 19468.     Merrymead Farm Market Premium Ice Cream; Chocolate Cookie Dough; Half Gallon; Dist. By Merrymead Farm Market, 2222 Valley Forge Road, Lansdale, PA.    Heritage's Old Fashioned Premium Ice Cream; Half Gallon; Heritage's Dairy Stores, Thorofare, NJ 08086;  Chocolate Chip Cookie Dough.    Heritage's Old Fashioned Premium Ice Cream; Chocolate Chip Cookie Dough; One Pint; Heritage's Dairy Stores, Thorofare, NJ 08086.
DF HG-525 units; DF PT- 520 units; Merrymead-44 units; Heritage HG-80 units;
The firm is recalling Chocolate Chip Cookie Dough as product labels failed to declare the allergens; wheat and Soy (from soy lecithin) as ingredients.
Nelson's Dutch Farms; Cookies & Cream; Half Gallon, Nelson's Ice Cream, Inc., Royersford, PA 19468;    Nelson's Dutch Farms; Cookies & Cream; One Pint; Nelson's Creamery, LLC; Royersford, PA 19468.    Heritage's Old Fashioned Premium Ice Cream; Cookies & Cream; Half Gallon; Heritages Dairy Stores, Thorofare, NJ 08086.    Heritage's Old Fashioned Premium Ice Cream; Cookies & Cream; One Pint; Heritage's Dairy Stores, Thorofare, NJ 08086.    Merrymead Farm Market Premium Ice Cream; Cookies & Cream; Half Gallon; Dist. by Merrymead Farm Market, 2222 Valley Forge Road, Lansdale, PA.
Dutch Farm: HG - 675 units, PT - 536 units; Heritage HG- 80 units, PT - 160 units; Merrymead - 68 units.
The firm is recalling Cookies & Cream ice cream products as product labels failed to declare the wheat allergen or the  wheat ingredients.
Nelson's Dutch Farms; Cinnamon Carmel Swirl; Half Gallon; Nelson's Ice Cream, Inc., Royersford, PA 19468
The firm is recalling  Cinnamon Carmel Swirl as labels failed to declare the allergen Soy (from soy lecithin) as an ingredient.
Nelson's Dutch Farms; Cotton Candy; Half Gallon; Nelson's Ice Cream Inc., Royersford, PA 19468.    Merrymead Farm Market Premium Ice Cream; Cotton Candy; Half Gallon; Dist. By: Merrymead Farm Market, 2222 Valley Forge Road, Lansdale, PA;
Dutch Farm - 372 units; Merrymead - 32 units
The firm is recalling Cotton Candy ice cream as product labels failed to declare the allergen Soy (from soy lecithin) as an ingredient.
Nelson's Dutch Farms; Butterscotch Vanilla; Half Gallon  Nelson's Ice Cream, Inc., Royersford, PA 19468.    Merrymead Farm Market Premium Ice Cream; Butterscotch Vanilla; Half Gallon; Dist by: Merrymead Farm Market, 2222 Valley Forge Road, Lansdale, PA;
Dutch Farms - 717.5 cases, 2 units/case; Merrymead - 38 units
The firm is recalling Butterscotch Vanilla due to undeclared soy from soy lecithin.
Nelson's Dutch Farms; Death By Chocolate; Half Gallon; Nelson's Ice Cream, Inc., Royersford, PA 19468.     Nelson's Dutch Farms; Death By Chocolate; One Pint; Nelson's Creamery, LLC; Royersford, PA 19468.    Merrymead Farm Market Premium Ice Cream; Death By Chocolate; Half Gallon; Merrymead Farm Market, 2222 Valley Forge Road, Lansdale, PA.
DF HG - 548 units, PT - 440 units; MM - 8 units
The firm is recalling Death By Chocolate ice cream products as product labels failed to declare the soy allergen (from soy lecithin) as ingredient.
PA, NH, NY, TX, FL, MA, MD, CA, CO, NJ, GA, MN, MI, IL, OH, AZ, WI, TN, NC,  British Columbia
Listeria monocytogenes found on food contact surfaces and non-food contact surfaces.
Cashew Butter: Gefen Cashew Butter NET WT. POIDS NET 16OZ(1LB)454g UPC: 7 10069 40473 1
7464 x 16oz jars  (622 cases of 12 jars)
Pitted Dates 475 cases of 24 x 1 lb bags
chic-a-peas baked crunchy chickpeas sea salt net wt. 2.0 oz (57g) UPC: 8 53404 00403 3
chic-a-peas baked crunchy chickpeas fresh salsa net wt. 2.0 oz (57g); UPC: 8 53404 00407 1
Organic Pitted Date Paste, Net Wt. 40 LBS
Walnut Butter Roasted-Natural 70WALN04 28 x 40lb & 1 x 24lb
Dry Roasted & Salted Cashew Butter Net Wt: 40 LBS
chic-a-peas baked crunchy chickpeas falafel net wt. 2.0 oz (57g) UPC: 8 53404 00402 6
Organic Dry Roasted Cashew Butter Net Wt: 40 LBS
Roasted & Sea Salted Macadamia Nut Size 4 (Net weight 25 lb. vacuum packed cartons) (Wholesale)
Cashews, Whole Roasted & Salted: Organic Roasted & Salted Whole Cashews, Net weight 12 lb. and 25 lb. vacuum packed cartons (Wholesale) and Whole Roasted & Salted Cashews
USA (nationwide) including  Puerto Rico, and Internationally to Colombia
Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA
Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI  00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.
Worldwide distribution-US (nationwide) and countries of: Germany, Great Britain, Austria, Ireland, Netherlands, France, Italy, Sweden, and San Marino.
Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number  85455 (Marketed in U.S. only)    Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm;  Model/Part Number  85355 (Marketed OUTSIDE U.S. only)      The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.
Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed as 7mm x 38 mm x 80 cm. The complaint was the result of incorrect dimensional information (7mm x 38mm x 80cm) printed on the manifiold (catheter hub).  The complaint device physical dimensions matched the dimensional information displayed on the outer packaging and the device inner pouch.  This was the only complaint received for this non-conformance.
Domestic: NC.      Foreign: Argentina, Austria, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, France, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Netherlands Antilles, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Singapore, South Africa, South Korea, Spain, Thailand, Turkey, United Kingdom, Uruguay, Venezuela, & Vietnam.
VITEK 2 Gram Negative test kits containing colistin (cs01n)
The recalled product was sold in the firm's retail store in Nebraska and shipped to wholesale accounts in Iowa, Florida,  Nebraska, and Vermont.
1) Key Lime Dessert Cake, Grandma's Bake Shoppe, NET WT. 14 OZ. (400 g), UPC 8 24153 02582 2
CO, GA, IA, IN, LA, MN, TN, TX, and WI  Canada, Germany, India, and Japan
IMMUCOR TPHA Screen Test Cells, Catalog Number 0066826
Immucor's TPHA Screen Test Cells, with a decrease in sensitivity for detection of antibodies to Treponema pallidum over the shelf life, were distributed.
LifeSouth Community Blood Centers Inc - Birmingham Region
Blood product, with a low platelet count, was distributed.
Apheresis Platelets, Leukocytes Reduced, Irradiated
Blood product, which did not meet the acceptable product specifications, was distributed.
Blood Bank Of San Bernardino And Riverside Counties
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Maquet Datascope Corp - Cardiac Assist Division
Worldwide Distribution - (in over 100 countries) US (Nationwide)
The device failed to pump due to an electrical test failure code #58 (power up vent test fail), maintenance code #3, and an autofill failure which has been associated to a patient death due to the failure of the device to initiate therapy.
FL, MA, IL, IN, AL, SC, NC, RI, PA, MD, NY, NH, NV, WI
Clear Sea Brand - Raw Breaded Cod Tails 8 OZ. - Net wt. 10 lbs. (4.54 KG)
1,055,006 pounds (total distributed for all product)
Products recalled due to undeclared allergen -milk
Channel Brand - 2-3oz. Raw Breaded Haddock Cuts -  Net wt. 10 lbs. (4.54 kg)
1,055,006 pounds (total distributed for all product).
Trisome Foods Inc. - IQF Raw Breaded Scallop Delicacies 26/30 count - Net wt. 2x5LBS=10 lbs. (4.54kg)
Channel Brand 4OZ Raw Breaded Natural Flounder Fillets - Net Wt. 2X5=10lbs. (4.54KG)
ICYBAY - Raw Breaded Natural Flounder Fillets Approx - 5OZ  NET WT. 10LBS (4.54Kg)
Culinary Meal Creations- 2-3 oz. Raw Breaded White Fish Cuts  (Cod) - Net wt. 10 lbs. (4.54kg) - Packed for Haikui (US) Mr. Ocean Seafood Corp.
Channel Brand - Approx 4OZ Raw Breaded Swai Fillet - Net WT. 10 lbs (4.54 KG)
Diamond Chef 4OZ Raw Breaded Natural Flounder Fillets - 5 lbs. (2.72KG)
Ocean's Best - Raw Breaded Fish Portions- 4 OZ Pollock Squares  Net wt. 10 lb. (4.54 KG)
Nordic Fisheries - Raw Breaded Cod Fillet 8 OZ - NET WT. 5 LBS. (2.27 Kg)
Beaver Street Fisheries - Raw Breaded Tilapia Fillets  - Net wt. 10 lbs. (4.54 KG) -
Winsor Bay - Raw Oriental Breaded Fish Portions - 4 oz. Cod Tails - Net Wt. 10 lbs (4.54 KG)
Falcon Baie - 4 oz. Raw Breaded Cod Squares - Net Wt. 10 lbs (4.54 KG)
PRIMA - 3 OZ Raw Breaded Whiting Squares - NET WT 10 LBS. (4.54 KG.)  PRIMA - 4 OZ Raw Breaded Whiting Squares - NET WT 10 LBS. (4.54 KG.)
Fire House Brand - Raw Oriental Breaded Fish Portions- 4oz Cod Tails -  Net wt. 10 lb. (4.54 KG)
Colony Lane - 5 oz. Raw Breaded Styled Flounder Portions - Net Wt. 2 x5 = 10 lbs. (4.54 KG)
Sea Best - 1.8oz. Raw Breaded Pollock Sliders -Net wt. 10 lbs. (4.54 kg)  Packed for: Beaver Street Fisheries
Deli Cod- For Deli Use Only- Breaded Cod - Net wt. 10 lbs. (4.54 kg)- Dist. By Beaver Street Fisheries
Channel Brand - Raw Breaded Bay Scallops Halves - Net wt/ 10lb. (4.54 KG)
Pacific Dynasty - Raw Breaded Cod Square 4 OZ - NET WT. 10 LBS (4.54 KG)
Channel Brand - 4oz. Raw Breaded Haddock Tails  Net wt. 10lb (4.54 KG)
Beaver Street Fisheries - Raw Breaded Deli Cod - NET WT. 10.0 lb (4.54kg)
Falcon Baie - Raw Breaded Natural Flounder 2-3 OZ  Net Wt. 10 lbs. (4.54 KG) Lot# 23634, Lot #23367  Falcon Baie- Raw Breaded Natural Flounder Fillets 3OZ- Net Wt. 10lbs (4.54 KG) - Lot# 22790, 23366  Falcon Baie Raw Breaded Natural Flounder Fillets 4 OZ - Net Wt. 10 lbs. (4.54KG) - Lot #'s 23120, 22789  Falcon Baie Raw Breaded Natural Flounder Fillets 5 OZ - Net Wt. 10lbs. (4.54KG) - Lot# 23368
North Atlantic 5OZ. Raw Breaded Cod - Net Wt. 10 lbs (4.54KG)
Channel Brand - Raw Breaded Bay Scallops - Net wt/ 10lb. (4.54 KG)
ICYBAY Raw Breaded Natural Shaped Cod Nuggets 1 OZ -  NET Wt. 10 LBS. (4.54Kg)
ICYBAY - Raw Breaded Scallops 30-40CT/LB -  Net Wat 2/5 LBS. (4.54Kg)
Ocean's Best Raw Breaded Fish Portions - 3 OZ COD. - Net Wt. 10 lb. (4.54KG)
Colony Lane - 4oz Raw Breaded Styled Pollock Portions - Net Wt. 2X5=10 lbs. (4.54 KG)   Colony Lane - 5oz Raw Breaded Pollock Styled Portions - Net Wt. 2X5=10lbs (4.54 KG)
G&W Brand -  Raw Breaded Cod Tails 4 oz -  Net Wt. 10 lbs (4.54 KG)
North Atlantic Brand - Approx8OZ Raw Breaded Swai Fillet - NET WT. 10lbs (4.54KG)
Prima - 4OZ Raw Breaded Haddock Squares - NET WT. 10 lbs. (4.54 KG)
ICYBAY - Raw Breaded AK Pollock Square 4OZ - NET WT. 10 LBS. (4.54Kg)
Ocean's Best Raw Breaded Fish Squares - 4 OZ COD. - Net Wt. 10 lb. (4.54KG)
Winsor Bay- Raw Oriental Breaded Fish Portions - 4 oz. Haddock Tails - Net wt. 10 lbs (4.54.KG)
Channel Brand - 5oz. Raw Breaded Cod Tails -  Net Wt. 10 lb. (4.54 KG)
Channel Brand - 1-3 oz Panko Breaded Tilapia - Net Wt. 10 lbs. (4.54 kg)
Checkers/Rally's Fish Breaded 2.5oz, 120-128 Count, Net Wt. 20 LBS
Channel Brand - 4OZ Raw Breaded Pollock Squares - Net wt.10 lbs. (4.54 kg)   Channel Brand- 4 oz. Raw Breaded Pollock Squared Net Wt. 10 lb. (4.54 KG)
Sea Best - 4oz. Raw Breaded Pollock Squares (Whole Muscle Pollock) -Net wt. 10 lbs. (4.54 kg)  Packed for: Beaver Street Fisheries
1,055,006 pounds (total of distributed products)
North Atlantic - 4 OZ Raw Breaded Pollock Tails - NET WT. 10 lbs. (4.54 KG)
Winsor Bay - Raw Oriental Breaded Fish Portions - 4 oz. Flounder Tails - Net Wt. 10 lbs (4.54 KG)
Winsor Bay- Raw Oriental Breaded Fish Portions - 4 oz. Cod Squares - Net wt. 10 lbs. (4.54 KG)
Deli Tilapia - For Deli Use Only - Breaded Tilapia - Net wt. 10 lbs. (4.54 KG) - Dist. by: Beaver Street Fisheries
Channel Brand - 4 oz. Raw Breaded Cod Tails NET WT. 10 lbs. (4.54 KG)
Ocean's Best- Raw Breaded Natural Flounder Fillets 4OZ - Net wt. 10lb. (4.54 KG)
Colony Lane - 4 oz. Raw Breaded Panko Flounder Fillets - Net Wt.2X5=10lbs. (4.54KG) - Lot 22938  Colony Lane - 5 oz. Raw Breaded Panko Flounder Fillets -  Net Wt.2X5=10lbs. (4.54KG) -Lot 23045  Colony Lane - 5 oz. Raw Breaded Panko Flounder Fillets -  Net Wt. 5lbs. (2.27 KG) -Lot 22935
North Atlantic 4 oz. Raw Breaded Cod Tails. Net Wt. 10 lbs (4.54KG)
North Atlantic 4 oz. Raw Breaded Cod Tails - NET WT. 10 lbs (4.54KG)
Nordic Fisheries - Raw Breaded Haddock Tails 5oz Net Wt. 2 x 5 lbs. (4.54 KG)
Nordic Fisheries - Raw Breaded Haddock Squares 4oz  - Net Wt. 2 X 5 lbs. (4.54 KG)
Nordic Fisheries - Raw Breaded Cod Tails 4 Oz  -Net Wt. 2x5 lbs. (4.54KG)   Nordic Fisheries - Raw Breaded Cod Tails 5 OZ - Net Wt. 2x5 lbs. (4.54 KG)
Nordic Fisheries - Raw Breaded Cod Tails 8 OZ - Net Wt. 2x5 lbs. (4.54 KG)
Ocean's Best - Raw Breaded Fish Squares ( 3OZ Pollock Squares) -  Net Wt. 10 lb (4.54 KG)  Ocean's Best - Raw Breaded Fish Squares ( 4OZ Pollock) Net Wt. 10 lb. (4.54 KG)
Sea Best - 4oz. Raw Breaded Cod Squared (Whole Muscle Cod) -Net wt. 10 lbs. (4.54 kg)  Packed for: Beaver Street Fisheries
North Atlantic - 4 OZ Raw Breaded Cod Squares - Net wt. 10 lbs. (4.54 kg)
MI, PA, NC, VA, TX, IL, NY, NJ, FL, OH, CA, CO
Lam Sheng Kee Frozen White Fish Ball NET WEIGHT: 32.1 OZ
Lam Sheng Kee Frozen Fried Fish Ball NET WEIGHT: 227g (8oz)
Lam Sheng Kee Frozen Fried Tofu NET Weight 240g(8.5 OZ)
A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients.
US, Canada, China, Croatia, Finland, France, Germany, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Morocco, Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, United Kingdom, Viet Nam
Beckman Coulter PK7300(R) Automated Microplate System, Catalogue Numbers:   N3209000 and N2007600
Beckman Coulter's PK7300, associated with a defect or glitch with the dispensing monitoring board, was distributed.
NutiLight Protein + Pistachio Spread, Net WT 11oz (312gr), NATUREFOOD 2010 COMPANY, PALM COAST, FL 32137 USA
US Distribution to the states of : CA, GA, MN, FL, NY, IL, TX
Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Catheter with 3M(TM) SteriStrip(TM), (1) Pump Tubing Set, (1) Drainage Bag.  Medtronic Navigation, Inc. Louisville, CO  80027
Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not be capable of creating a seal around the optical fiber to ensure adequate saline flow through the cooling system. When the TBA is unable to seal around the optical fiber, low retention force to the optical fiber may occur, causing saline to leak out of the TBA.
Penrose-St Francis Health Services Blood Bank
Blood product, in which initial donor Chagas testing was not performed, was distributed.
American National Red Cross Southeastern Michigan Region
Blood and Blood Products for Reprocessing
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Product was distributed to the firm's retail grocery stores in eastern Missouri and western Missouri.
Dierbergs Kitchen, Grilled Chicken Caesar Wrap, NET WT. 10 oz, UPC 0 233983 804994
Dierbergs Kitchen, Santa Fe Grilled Chicken Wrap, NET WT. 11 oz, UPC 0 231789 804996
Dierbergs Kitchen, Santa Fe Grilled Veggie Wrap, NET WT. 12 oz, UPC 0 234188 804994
Dierbergs Kitchen, Classic Pinwheel Appetizer Wrap Platter, 12 ct, UPC 232669 316998
PerkinElmer 226 Sample Collection Device    The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.
PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.
Morski Brands Inc. dba Dawn's Fresh Foods
DFS Cranberry Pumpkin Salad. Contains 4 / 8 Lb Bags, Net WT 32 lbs Item # 12071, Manufactured for Direct Food Service by Dawns Foods - Portage, WI.
Cranberry Pumpkin Salad prepared with pumpkin seeds that might be contaminated with Listeria monocytogenes.
Anarkali Peshawari Naan Bread  Frozen 15oz. retail plastic pouch  24 retail units per wholesale case
All product on market within expiration: 7/1/2017 or prior, ink-jetted on the back of the package
Worldwide Distribution - US (Nationwide including PR) and Canada
Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan, IL    A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.
Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL    A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
PB Crave, Coconut Milk Chocolate Peanut Butter Spread, NET WT 16 OZ (1 LB) -454 g.    Plastic jars, 6 per case.
allergen statement under the ingredient list  fails to list coconut.
Product was shipped to the following states: MN, NC & TX
HY-TOP Rice MIX CHICKEN FLAVORED RICE & VERMICELLI WITH SEASONINGS NET WT 6.9 OZ (196g)
The firm failed to declare wheat in the ingredient statement.
US and worldwide: CA, CN, CL, DE, ES, GB, FR, HR, IL, IN, IT, JO, JP, LB, NZ, QA, VN
AllSet+ Gold SSP ABC Low Resolution Kit, Catalog 54340D
AllSet Gold SSP test kits, containing the incorrect allele specificity information for two primer mixes, were distributed.
AllSet+ Gold SSP C Low Resolution Kit, Catalog 54330D
AllSet+ Gold SSP C Locus High Resolution Kit, Catalog 54030D
Diagnostics Ultrasound System  Ultrasounds System Sonimage HS1
The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.
Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits.
STOCKERT Heater-Cooler System 3T, 127V/60 Hz
STOCKERT Heater-Cooler System 3T, 120V/60 Hz
STOCKERT Heater-Cooler System 3T, 208V/60 Hz
STOCKERT Heater-Cooler System 3T, 240V/60 Hz
STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz
GA, LA, IL, AL, CO, CA, TX, IL, FL, AZ, WI, MD, OH, ID, NC, OK, NV, MO,
BioHealth Pasture Fed Precision Blend Time Release Protein: Cookies and Cream Flavor;  Sold in 2 lb.(960G)  UPC 6 42014 59446 7 and 4 lb.  (1,920G) UPC 6 42014 59447 4 white plastic containers.
Oklahoma Blood Institute - Sylvan N Goldman Center
Apheresis Platelet, labeled with an incorrect volume, was distributed.
Apheresis products, which may have been exposed to unacceptable temperatures during shipment, were distributed.
1675 Aurora Ct. Ei- 2049 Aurora Co 80045
Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.
Blood product for which quality control procedures were not performed, was distributed.
Blood product, manufactured without additive solution, was distributed.
PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0811-40
Lack of Assurance of Sterility; product has the potential to leak.
Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0302-05
fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0260-40
PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40
fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0226-40
BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Preservative Free (Waste From 250 mL Bag), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0060-40
fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride  Injection Bag (Total fentaNYL Dose 1250 mcg/ 250 mL), Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0201-40
NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0774-40
PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0820-40
NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0771-40
PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40
fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-40
EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only,  SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---  NDC# 70004-0613-40
fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---  NDC# 70004-0254-40
fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0290-40
fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-05
NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0775-40
BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free (Total Dose Bupivacaine 312.5 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0062-40
BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (Total Dose Bupivacaine 500 mg per 250 mL), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0066-40
PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---  NDC# 70004-0815-40
PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---  NDC# 70004-0810-40
PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0809-40
Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0832-40
fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0230-40
PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 882PHENYLephrine 100 mg 1 Knoedl Ct Little Rock, AR 72205 ---  NDC# 70004-0813-40
ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---  NDC# 70004-0600-11
Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40
PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0811-59
fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syringe, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0225-24
fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40
ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 115 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0524-32.
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have the potential to leak.
fentaNYL (as citrate) 10 mcg per mL  in 0.9% Sodium Chloride, (Total fentaNYL Dose 1,000 mcg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0202-32.
Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0541-35.
PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR  72205 (877) 550-5059; NDC: 70004-0810-32.
MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0737-32.
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 100 mg/100 mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205, (877) 550-5059; labeled as a) NDC: 70004-0100-59; b) NDC: 70004-100-58.
Smiths Medical CADD Blue-Striped IV Administration Set, REF 21-7036-01, Sterilized using ethylene oxide.
The label of the CADD Blue-Striped Administrative Set is missing the expiration date, which is considered a regulatory compliance issue for Canada.