Recalling Firm
Stryker Instruments Div. of Stryker Corporation
Bevovations, LLC dba New England Apple Products Company
Central Texas Regional Blood & Tissue Center
Transplant Services Center UT Southwestern Medical Center

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Worldwide Distribution - US including AZ CA CO FL GA IL IN KS MD MI MN MS OH OR PA SC SD TX VA WA and WI Internationally to Canada, Australia Austria Colombia Denmark France Germany Korea New Zealand Russia South Africa and Thailand
IL, OH, WI, NV, AL, AZ, PA, TN, MI, MN, and IN
Product was shipped to the following states: AL, AZ, GA, IL, IN, KY, MD, MI, NV, OH, PA, WI & WV.
Worldwide Distribution - US Distribution including Puerto Rico and to the countries of : Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Poland, Spain Singapore and Venezuela.
Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, , Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Turkey, United Arab Emirates, UK, and Vietnam.
US Nationwide in the states of: AL, AR, AZ, CA, CT, FL, GA, ID, IL, KS, LA, MO, MS, NY, OH, OK, OR, TN, TX, and WI
Product distributed to northwest Iowa and southeast South Dakota
Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany.
Worldwide distribution - US Nationwide in the states of: AZ, CA, CT, GA, LA, NV, OH, TX and in the country of Mexico.
US Nationwide distribution in the states of : AR, AZ, CO, IA, IL, KS, KY, LA, MI, MO, MS, MT, NC, ND, NE, NM, OH, OK, SD, and TX and Puerto Rico
US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, SC, SD, TN, TX, and WA
US Nationwide Distribution in the states of AR, CA, CO, FL, IL, NJ, NV, OR, PA, TX, and WA
Nationwide and other foreign consignees. No VA/govt/military or VA consignees.
sold at ALDI retail stores in the following states: FL, IA, IL, KY, MI, OH, WI, WV.
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : United Arab Emirates, Argentina, Armenia, Austria, Australia, Azerbaijan, Bahrain,Bangladesh, Belgium, Bolivia, Brazil, Canada, Chile, Columbia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Ethiopia, Egypt, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Myanmar, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, Venezuela, Vietnam and United Kingdom,
North America / South America, please see attached list.
Worldwide Distribution - US Distribution and to North America.
distributed in District of Columbia, Delaware, Florida, Georgia, Illinois, Maryland, North Carolina, South Carolina, Virginia, and Wisconsin.

Product Description
SmartSite Add-On Bag Access Device, Model No. 10013365
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
Colby-Jack (or CoJack; Marble) cheese. All affected product private labeled for other companies. Brands: Guggisberg; Dutch Farms; Meijer; Amish Classics; Lipari Old Tyme; Laubscher; Walnut Creek; Copperwood; Dietz & Watson; Banquet; Product packaged as: 6lb deli horns (4 diameter x 13 long cylinder) 2 or 4 per case; 15lb long horns (6 diameter x 13 long cylinder) 2 or 4 per case; 1lb Cut and Wrap ( 4 or 6 diameter x 1 thick pucks) 10 per case Products package in clear plastic bags. Bags sealed by vacuum sealing and shrink wrapping.
Pepper-Jack cheese. All affected product private labeled for other companies. Brands: Guggisberg; Dutch Farms; Amish Classics; Lipari Old Tyme; Laubscher; Walnut Creek; Copperwood; Product packaged as: 6lb deli horns (4 diameter x 13 long cylinder) 2 or 4 per case; 15lb long horns (6 diameter x 13 long cylinder) 2 or 4 per case; 1lb Cut and Wrap ( 4 or 6 diameter x 1 thick pucks) 10 per case Products package in clear plastic bags. Bags sealed by vacuum sealing and shrink wrapping.
White Colby cheese. All affected product private labeled for other companies. Brands: Walnut Creek Product packaged as: 15lb long horns (6 diameter x 13 long cylinder) 2 per case; Products package in clear plastic bags. Bags sealed by vacuum sealing and shrink wrapping.
Cheddar cheese. All affected product private labeled for other companies. Brands: Guggisberg; Amish Classics; Dutch Farms; Banquet; Product packaged as: 6lb deli horns (4 diameter x 13 long cylinder) 2 or 4 per case; 15lb long horns (6 diameter x 13 long cylinder) 2 or 4 per case; 1lb Cut and Wrap ( 4 or 6 diameter x 1 thick pucks) 10 per case Products package in clear plastic bags. Bags sealed by vacuum sealing and shrink wrapping.
Cheese by-products. Fines small particles of cheese curds off of the whey. Pressed Horns end of day cheese left over that is not enough to press in a tower or deli press gets pressed using the traditional press and sold as pressed horns. Split Horns co-mingled cheese portion produced in tower when changing from processing one cheese variety to another. #2 during processing if cheese does not meet specification (too dry, not enough salt). Trims ends that are removed from horns before packaged. Products package in clear plastic bags. Bags sealed by vacuum sealing and shrink wrapping.
Pepper Colby-Jack (or: Pepper Marble Jack; Lightning Jack; Thunder Jack; Firecracker; Jalapeno Jack; Jumping Jack) cheese. All affected product private labeled for other companies. Brands: Guggisberg; Dutch Farms; Amish Classics; Lipari Old Tyme; Walnut Creek; Product packaged as: 6lb deli horns (4 diameter x 13 long cylinder) 2 per case; 1lb Cut and Wrap ( 4 or 6 diameter x 1 thick pucks) 10 per case Products package in clear plastic bags. Bags sealed by vacuum sealing and shrink wrapping.
Semi Soft cheese with yogurt cultures and with or without vegetables. All affected product private labeled for other companies. Brands: Guggisberg; Product packaged as: 6lb deli horns (4 diameter x 13 long cylinder) 2 per case; Products package in clear plastic bags. Bags sealed by vacuum sealing and shrink wrapping.
Amish Creamery (or Butter) cheese. All affected product private labeled for other companies. Brands: Guggisberg; Amish Classics; Product packaged as: 6lb deli horns (4 diameter x 13 long cylinder) 2 per case; 15lb long horns (6 diameter x 13 long cylinder) 2 per case; 1lb Cut and Wrap ( 4 or 6 diameter x 1 thick pucks) 10 per case 39 slicer 4 diameter x 39 long cylinder (single per case) Products package in clear plastic bags. Bags sealed by vacuum sealing and shrink wrapping.
Colby cheese. All affected product private labeled for other companies. Brands: Guggisberg; Dutch Farms; Meijer; Amish Classics; Lipari Old Tyme; Laubscher; Walnut Creek; Copperwood; Dietz & Watson; Banquet; Product packaged as: 6lb deli horns (4 diameter x 13 long cylinder) 2 or 4 per case; 15lb long horns (6 diameter x 13 long cylinder) 2 or 4 per case; 1lb Cut and Wrap ( 4 or 6 diameter x 1 thick pucks) 10 per case 39 slicer 4 diameter x 39 long cylinder (single per case) Products package in clear plastic bags. Bags sealed by vacuum sealing and shrink wrapping.
Farmers cheese. All affected product private labeled for other companies. Brands: Guggisberg; Amish Classics; Walnut Creek; Product packaged as: 6lb deli horns (4 diameter x 13 long cylinder) 2 per case; Products package in clear plastic bags. Bags sealed by vacuum sealing and shrink wrapping.
GUGGISBERG GARDEN VEGETABLE NATURAL CHEESE INGREDIENTS: Pasterized Milk, Cultures, Red & Green Pell Peppers, Parsley, Salt, Onion, Celery, Carrots, Cucumbers, Califlower, Enzymes, LIve Yogurt Cultures 11275 W 250 N MIDDLEBURY, IN 46540
Cheddar Cheese sold under the following brand names: Amish Classic 6 lb, Banquet Better Long Horns, Dutch Farms 6 lb & Guggisberg 12 oz, 1 lb & 6 lb,
Amish Creamery Butter Cheese Sold under the following brand names: Amish Classic 6 lb & 15 ib and Guggisberg 15 ib Distributed by: Guggisberg Cheese, 5060 S.R. 557, Millersburg, OH 44654
Pepper Jack Cheese sold under the following brand names: Amish Classic 6 lb, Dutch Farms 6 lb, Guggisberg 6 lb, 14 lb, Mini Rounds & Long Horn & Walnut Creek 6 lb
Marble Cheese sold under the following brand names: Amish Classic 6lb & 15lb, Dietz & Watson 6lb, Dutch Farms 6lb, Guggisberg 6lb, & 15lb, Lipari 6lb & 15lb, Meijer & Walnut Creek 6lb & 15lb
Thunder Jack Cheese sold under the following brand names: Amish Classic Firecracker & Guggisberg
Colby Cheese sold under the following brand names: Amish Classic 6lb & 15lb, Dietz & Watson 6lb, Dutch Farms 6lb, Guggisberg 8oz, 12oz, 1ib, 6lb, 14lb & 15lb, Lipari 6lb & 15lb, Meijer & Walnut Creek 6lb & 15lb
Farmers Cheese sold under the following brand names: Amish Classic 6lb & 15lb, Guggisberg 12oz, & 6lb Mini Horn, Walnut Creek 6lb
VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics manufactured by Siemens. The VANC product has a maximum on-analyzer stability of < 7days. The on-analyzer stability of each VITROS VANC Reagent pack is determined by the system. Once the VANC reagent pack is loaded on the system, the on-analyzer stability time is continuously adjusted based upon both the amount of time the reagent pack is on the analyzer and the number of tests remaining in the pack. The method by which the on-analyzer stability of the VITROS VANC Reagent is determined is stated in the reagents Instructions for Use.
HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
hCG Body Shaper, Highly Purified Human Chorionic Gonadotrophin 5000 IU, Colloidal Silver B12, Stabilizers/Excipients, Not For Medical Use, Must Be Refrigerated, Distributed by HCG Body Shaper, St. Peters, MO
Stryker SmartLife Large Aseptic Housing (7126-120-000)
uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.
Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 Sandoz Princeton, NJ 08540, NDC 61314-206-15
Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15
Almond Tea Ring, Valley Bakery, Rock Valley, IA, 1 count. UPC 290401508001, packaged in clear plastic bags
Holstein Crimp Bread, Valley Bakery, Rock Valley, IA, 1 count. UPC 290113203607, packaged in clear plastic bags
Cocktail Buns, Valley Bakery, Rock Valley, IA, 12 count. UPC 290201203501, packaged in clear plastic bags
Large Hamburger Buns, Valley Bakery, Rock Valley, IA, 12 count. UPC 290707404002, packaged in clear plastic bags
Large Hamburger Buns, Valley Bakery, Rock Valley, IA, 4 count. UPC 290223201401, packaged in clear plastic bags
Raspberry Tea Ring, Valley Bakery, Rock Valley, IA, 1 count. UPC 290400306004, packaged in clear plastic bags
Wheat Tea Rolls, Valley Bakery, Rock Valley, IA, 12 count. UPC 290219203556, packaged in clear plastic bags
Sno-Flake Buns, Valley Bakery, Rock Valley, IA, 12 count. UPC 290713203606, packaged in clear plastic bags
Hamburger Buns, Valley Bakery, Rock Valley, IA, 12 count. UPC 290202003804, packaged in clear plastic bags
White Crimp, Valley Bakery, Rock Valley, IA, 1 count. UPC 290113203607, packaged in clear plastic bags
Large Wheat Hamburger Buns, Valley Bakery, Rock Valley, IA, 12 count. UPC 290209304102, packaged in clear plastic bags
Large Hamburger Buns, Valley Bakery, Rock Valley, IA, 8 count. UPC 290225402752, packaged in clear plastic bags
Tea Rolls, Valley Bakery, Rock Valley, IA, 12 count. UPC 290215303502, packaged in clear plastic bags
Steak Buns, Valley Bakery, Rock Valley, IA, 6 count. UPC 290214603207, packaged in clear plastic bags
Blueberry Tea Ring, Valley Bakery, Rock Valley, IA, 1 count. UPC 290404306000, packaged in clear plastic bags
Raisin Buns, Valley Bakery, Rock Valley, IA, 12 count. UPC 290211803006, packaged in clear plastic bags
Raisin Bread, Valley Bakery, Rock Valley, IA, 1 count. UPC 290104404006, packaged in clear plastic bags
Rusk Buns, Valley Bakery, Rock Valley, IA, 1 count. UPC 290212603209, packaged in clear plastic bags
Strawberry Tea Ring, Valley Bakery, Rock Valley, IA, 1 count. UPC 290406306006, packaged in clear plastic bags
Wheat Hamburger Buns, Valley Bakery, Rock Valley, IA, 12 count. UPC 290218903907, packaged in clear plastic bags
Hot Dog Buns, Valley Bakery, Rock Valley, IA, 8 count. UPC 290206803004, packaged in clear plastic bags
Cinnamon Swirl Crimp Bread, Valley Bakery, Rock Valley, IA, 1 count. UPC 290113203607, packaged in clear plastic bags
Brat Buns, Valley Bakery, Rock Valley, IA, 6 count. UPC 290200602603, packaged in clear plastic bags
Apple Tea Ring, Valley Bakery, Rock Valley, IA, 1 count. UPC 290400306006, packaged in clear plastic bags
Specialty Crimp, Valley Bakery, Rock Valley, IA, 1 count. packaged in clear plastic bags
Apricot Tea Ring, Valley Bakery, Rock Valley, IA, 1 count. UPC 290403306001, packaged in clear plastic bags
Cherry Tea Ring, Valley Bakery, Rock Valley, IA, 1 count. UPC 290405306009, packaged in clear plastic bags
Blood and Blood Products for Reprocessing
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
Cedeira Octopus in Oil Spiced Piquant, Net Weight 4.4oz (125g)
PERFORMIX(TM) CREA-BEAD, MULTI-PHASE CREATINE, BLUE RAZZ ICE, NET WT 11.1 OZ (315G), Distributed by Performix LLC, 221 S. Cherokee St., Denver, CO 80223, UPC 8 11274 02204 5
PERFORMIX(TM) CREA-BEAD, MULTI-PHASE CREATINE, UNFLAVOURED, (a) 30 SERVINGS, UPC 8 11274 02239 8; (b) 45 SERVINGS, Distributed by Performix LLC, 221 S. Cherokee St., Denver, CO 80223, UPC 8 11274 02203 8
BULK PRODUCT: MYPROTEIN, MYPRE Europe Base, bulk powder used for further processing in Europe
MYPROTEIN, MYPRE V2(TM) Net Wt. 17.6 Oz (1.1 lb) /500g, Blue Raspberry, preworkout, 500g, THE HUT GROUP(R), 1350 Cedar Grove Park, Shepherdsville, KY, UPC 5 065104 570111
MP MUSCLEPHARM, ASSAULT, ENERGY + STRENGTH, THE ATHLETES PRE-WORKOUT, GREEN APPLE, 11.75 OZ (O.73 LBS) (333G), Exclusively Developed & Manufactured for: MusclePharm Corp., 721 Ironton St., Denver, CO 80239, UPC 6 53341 04601
Muscle Meds(TM) PERFORMANCE TECHNOLOGIES, BIOENGINEERED BEEF PROTEIN ISOLATE CARNIVOR(TM) Dietary Supplement, Net Wt. 2 lbs. (904.4g), ADVANCED FLAVOR TECHNOOGY FRUIT PUNCH, (a) 904.4g, (b)1808.8g, Manufactured for and Distributed by: MuscleMeds Performace Technologies 165 Clayton Road, West Caldwell, NJ 07006, UPC 08 91597 00214 6
USN B4 -BOMB EXTREME PRE-WORKOUT, LIME LEMONADE FLAVOUR, 300g, USN North America, 1560 Sawgrass Corporation Pkwy, 4th Floor, Sunrise, FL, 33323
5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected between two or more pedicle screws to create a pedicle screw construct. Indications for Use: The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.
Whole Foods Market Made Right Here 6pk Banana Choc Chip Muffins, 6 pack. Net Wt. 1 lb 1 oz.
Apple Cider packed under the following labels: RUDY'S BLEND APPLE CIDER, 1 GAL. (3.78L), UPC: 8 56005 00344 3; RUDY'S BLEND APPLE CIDER; 1/2 GAL (1.89L), 8 56005 00434 6; FRESHLY PRESSED APPLE CIDER Carlson Orchards Harvard, Mass, 1/2 GAL (1.89L), 8 56005 00323 8; FRESHLY PRESSED APPLE CIDER Carlson Orchards Harvard, Mass, 1 GAL. (3.78 L), 8 56005 00324 5; FRESHLY PRESSED APPLE CIDER Carlson Orchards Harvard, Mass, 16 FL. OZ. (473mL); LYMAN ORCHARDS Pure Sweet Apple Cider, 1 GAL (3.78l), 0 27894 44972 2; LYMAN ORCHARDS Freshly Pressed Apple Cider, 16 OZ (473ml), 0 27894 44672 1
Apple Cider with Potassium Sorbate, packed under the following labels: RUDY'S BLEND APPLE CIDER; 1 GAL. (3.78L), UPC: 8 56005 00344 3; RUDY'S BLEND APPLE CIDER, 1/2 GAL (1.89L), 8 56005 00434 6; FRESHLY PRESSED APPLE CIDER Carlson Orchards Harvard, Mass, 1/2 GAL (1.89L), 8 56005 00323 8; FRESHLY PRESSED APPLE CIDER Carlson Orchards Harvard, Mass, 1 GAL. (3.78 L), 8 56005 00324 5; FRESHLY PRESSED APPLE CIDER Carlson Orchards Harvard, Mass, 16 FL. OZ. (473mL); LYMAN ORCHARDS Pure Sweet Apple Cider, 1 GAL (3.78l), 0 27894 44972 2; LYMAN ORCHARDS Freshly Pressed Apple Cider, 16 OZ (473ml), 0 27894 44672 1
Menu Del Sol Beans and Cheese Burritos, UPC 45230-05601, 8 units/case, 32oz (2lb)
Premium Hunt's Chili Kit, Total NET WT 44.8 OZ (2.80 LB) 1.27kg; Directions: 1) Cook and stir meat in saucepan over medium-high 7 minutes or until done; drain. 2) Stir in all remaining ingredients; simmer 10 minutes, stirring occasionally. Con Agra Foods, P.O BOX 3768, Dept. Hunts, Omaha, NE 68103-0768 USA
Econo, Estilo Pulpo en Aceite, Octopus Style in Oil, Net Wt. 4oz (115g)
Econo, Estilo Pulpo al Ajillo, Octopus Style with Garlic Flavor, Net Wt. 4oz (115g)
Econo, Estilo Pulpo a la Marinera, Octopus Style Marinera Sauce, Net Wt. 4oz (115g)
ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Product Usage: The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX) I Plate Product Usage: Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. Chocolate II Agar is an enriched medium for the isolation and cultivation of Neisseria species.
Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROW g+ard Blue Plus catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied
Apheresis Platelets, Leukocytes Reduced, Irradiated
Season's Choice Garden Fresh Sweet Peas, Net Wt 16 oz (1lb) 454g, Keep Frozen. UPC 41498-164294.
Red Blood Cells, Leukocytes Reduced, Irradiated
Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9.
Phenylephrine 2.5%, Tropicamide 1%, 15 mL Multi-Dose Ophthalmic (spelled Opthalmic) Drops in a bottle, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1300, barcode 3 70285 13001 4.
Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1011, barcode 3 70285 10111 3.
Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4.
Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.
Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.
Triamcinolone Acetonide 40 mg/mL, Lidocaine HCl 10 mg/mL , 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1020, barcode 3 70285 10201 1.
Organic Marketside Spring Mix, net Wt. 5 oz. (142g) packed in rigid plastic container, UPC code 6 8113132897 5.
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
JAP001 Jalapeno Powder, 44 lbs., cardboard carton with internal polybag
Shrimp Satay Hot Dry Shrimp-Chili Sauce, Net: 6 and 9oz , 12 units/case
Lemongrass Satay, Net: 9oz (265gr), 12units/case and 1/2 gallon, 6 units/case
The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs.
Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis Platelets, Platelet Additive Solution Added, Leukocytes Reduced
01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal surgery
Roundy's Southern Style Diced Hash Browns, frozen, net wt. 32 oz per package, UPC 0 01115 05501 9. Harris Teeter Southern Style Diced Hash Browns, frozen, net wt. 32 oz per package, UPC 0 07203 64902 0.
Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured by Sandoz, Inc., 506 Carnegie Center, Suite 400, Princeton, NJ 08805, Distributed by: McKesson Packaging Services, 7101 Weddington Rd, Concord, NC 28027, NDC 63739-678-10

Product Quantity
4,121,370.18 lbs (total cheese/cheese products)
1008 cases consisting of 25 tins, 4.4 oz. each tin.
5,458 cases (4 chili kits per case, 1 seasoning packet per kit)
1920 Cases (24 packages per case); Expanded: 1568 cases
476 cartons (10x10 blister packs per carton)

Reason for Recall
CareFusion is recalling the SmartSite Add-On Bag Device due to reports of separation and/or leakages between the spike port and the drip chamber spike. A separation or leak can cause a delay of infusion, an interruption of infusion, exposure to medication or hazardous infusates, or underinfusion.
Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.
The firm was notified that the product may contain Listeria monocytogenes.
The firm was notified that the product may contain Listeria. monocytogenes
Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can occur after the reagent packs are loaded onto the analyzer and stored within the on-analyzer stability date.
Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, possibly contaminated with air, were distributed.
Blood products, which did not meet the acceptable product specifications, were distributed.
Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug
Stryker Instruments issued a notice of correction for an update to cleaning practices for the Stryker SmartLife Large Aseptic Housings following complaints of deterioration to the housing and the top and bottom housing separating at the weld. Using cleaning practices outside of the HIFU could lead to housing separating at the weld.
Surgical technique was revised to prevent static plate screws blocking mechanisms from disassociating.
Blood product, with an unacceptable pH, was distributed.
Bakery products which contain an ingredient which contain egg do not declare egg on the label
Blood product, labeled as leukoreduced but was not tested to verify White Blood Cell count, was distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to identified clinicians informing them that a new, improved splice kit is available.
The product is labeled as Octopus on its label display, while ingredients list Dosidicus Gigas, which is a scientific definition for Jumbo Squid. The firm was informed of this issue by FDA, and voluntarily decided to recall the product, because it appears to be misbranded.
A raw material initially failed testing Staphylococcus aureus. A retest was conducted with passing results but an out of specification investigation was not properly conducted leaving concern that the finished product could contain the bacterium.
The material type on the label may incorrectly state Ti6Al-4V ELI . The rods are composed of Cobalt Chromium.
Confirmed complaint of surface contamination of Listeria monocytogenes.
Product contains elevated levels of patulin.
Sigma Foods is recalling Bean and Cheese Burritos because it may be contaminated with Listeria monocytogenes.
Potential Salmonella contamination of spice packet within chili kits.
Product in principal display panel identified as Octopus and real content is squid.
CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . It was discovered that 0.018 in ViperWire Advance with Flextip product was packaged as a 0.014in ViperWire Advance with Flextip.
BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophilus influenzae 10211 and Haemophilus parainfluenza 51505 on the Chocolate Agar side of the plate. All other QC organisms are correctly recovered.
Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.
Blood products collected from a donor who traveled to a malarial endemic area were distributed.
Apheresis Platelet, labeled with an incorrect volume, was distributed.
The Season's Choice frozen peas, 16 oz., was tested and was positive for Listeria monocytogenes..
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed
Blood product collected from a donor who traveled to a malarial endemic area was distributed.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Apheresis product, with unacceptably high platelet concentrations, was distributed.
Apheresis product, in which residual WBC count was not performed, was distributed.
Foreign animal matter was allegedly found in a single container of the salad.
Evolution with Touch Control, the ultrasound system may display a triple image or an image with a dark band. For the triple image issue, the system repeats one-third of the aperture, but does not display the full field of view.
Potential contamination of product with Salmonella.
TP Food Processing, Inc. is recalling Lemongrass Satay and Shrimp Satay because the acidified sauces were not properly produced making them susceptible to contamination with Clostridium botulinum.
Savaria Concord Lifts has decided to initiate a recall of the Stairfriend, because of product defect. The product defect relates to poor quality of welding holding the seat post .
Blood products, collected in a manner that lacked assurance of sterility, were distributed.
Savaria Concord Lifts Inc has decided to initiate this recall of its Omega Incline Platform Lift because bolts can come loose causing the carriage to separate from the trolley and the unit to fail
Apheresis products, in which quality control for residual WBC count was not performed, were distributed.
Plateletpheresis products, lacking proper WBC quality control testing, were distributed.
Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
Southern Style Hash Brown products are recalled because they are contaminated with extraneous golf ball material
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
Supotent: Out of Specification result for assay test during routine stability testing.
Blood products were released for distribution based on incorrectly performed relevant Transfusion-Transmitted Infection testing.
Blood products, in which donor suitability was not adequately determined, were distributed.

Code Info
Part Name: OS Knee Universal Part Number: ORTHOsoft-UniTkr-2 Affected Lot: ORTHOsoft-UniTkr-2.3.2.6
All lots in market manufactured from 9/1/2016 to 1/27/2017 and distributed from 9/1/2016 to 2/7/2017. Lot numbers are printed on bag and case label. Lot# is the manufacturing date plus vat number (example: manufacturing date, 12/2/16; vat 7 = lot# 12/2/16 V7) Item #'s: W0205; L0204-85; L0202-86; L0202-70; L0202-65; L0202-64; D0204-63; D0202-86; D0202-83; D0202-82; D0202-72; D0202-71; D0202-70; D0202-65; D0202-64
All lots in market manufactured from 9/1/2016 to 1/27/2017 and distributed from 9/1/2016 to 2/7/2017. Lot numbers are printed on bag and case label. Lot# is the manufacturing date plus vat number (example: manufacturing date, 12/2/16; vat 7 = lot# 12/2/16 V7) Item #'s: L0502-86; L0502-70; D0504-63; D0502-86; D0502-83; D0502-65; D0502-71; D0502-70; D0502-64; W0505
All lots in market manufactured from 9/1/2016 to 1/27/2017 and distributed from 9/1/2016 to 2/7/2017. Lot numbers are printed on bag and case label. Lot# is the manufacturing date plus vat number (example: manufacturing date, 12/2/16; vat 7 = lot# 12/2/16 V7) Item #'s: L0352-64
All lots in market manufactured from 9/1/2016 to 1/27/2017 and distributed from 9/1/2016 to 2/7/2017. Lot numbers are printed on bag and case label. Lot# is the manufacturing date plus vat number (example: manufacturing date, 12/2/16; vat 7 = lot# 12/2/16 V7) Item #'s: W0405; L0404-85; L0402-70; D0402-83; D0402-71; D0402-70;
All lots in market manufactured from 9/1/2016 to 1/27/2017 and distributed from 9/1/2016 to 2/7/2017.
All lots in market manufactured from 9/1/2016 to 1/27/2017 and distributed from 9/1/2016 to 2/7/2017. Lot numbers are printed on bag and case label. Lot# is the manufacturing date plus vat number (example: manufacturing date, 12/2/16; vat 7 = lot# 12/2/16 V7) Item #'s: D0602-83; D0602-71; D0602-70; D0602-65; D0602-64; W0605
All lots in market manufactured from 9/1/2016 to 1/27/2017 and distributed from 9/1/2016 to 2/7/2017. Lot numbers are printed on bag and case label. Lot# is the manufacturing date plus vat number (example: manufacturing date, 12/2/16; vat 7 = lot# 12/2/16 V7) Item #'s: D1202-70 D1102-70
All lots in market manufactured from 9/1/2016 to 1/27/2017 and distributed from 9/1/2016 to 2/7/2017. Lot numbers are printed on bag and case label. Lot# is the manufacturing date plus vat number (example: manufacturing date, 12/2/16; vat 7 = lot# 12/2/16 V7) Item #'s: W1005; S1001; D1002-70; D1002-71; L1002-70
All lots in market manufactured from 9/1/2016 to 1/27/2017 and distributed from 9/1/2016 to 2/7/2017. Lot numbers are printed on bag and case label. Lot# is the manufacturing date plus vat number (example: manufacturing date, 12/2/16; vat 7 = lot# 12/2/16 V7) Item #'s: D0902-71; D0902-70; D0902-64
HeartWare HVAD System Controller Product numbers: 1401US, 1401XX, 1403US, 1407XX, and 1400 with the serial Number(s) lower than CON300000 HeartWare HVAD DC Adapter Product number: 1435 .
Manufacture Start Date for Affected Lots: 18-Mar-2015 Manufacture End Date for Affected Lots: 31-Jan-2017
Product Codes: ASY00116 and ASY00281 Serial # All patients with Drivelines splice repair performed prior April 2015
Part number X077-0420, lot number 041218
Part/Cat No. 221302 Lot / Serial No. 4365741
Production code G089B19, Best-if-used-by date of April 14, 2017
Henry Broch lot # 7549A. Shanghai Pecenp International Co., LTD batch # SP1630 (7549). Expiration date: 08/05/2018
Shrimp Satay 6oz Lot # 0611515 BBF Nov. 17 Lot# 027516 BBF Jul. 18 Lot # 039516 BBF Sept 2018 Shrimp Satay 9 oz Lot# 0612515 BBF Dec. 17 Lot # 0610516 BBF 17Oct18 Lot # 0510516 BBF Oct. 18 Lot# 037516 BBF Jul. 18 Lot# 0712516 BBF Dec. 18 Lot# 014516 BBF Apr. 18 Lot# 049516 BBF Sep. 18 Lot# 0510516 BBF Oct. 18
Lemongrass Satay 9oz Lot # 0612515 BBF Dec. 17 Lot# 027516 BBF Jul. 18 Lot #0411516 BBF Nov. 18 Lot# 0712516 BBF Dec. 18 Lemongrass Satay 1/2 Gallon Lot# 027516 BBF July. 18
s/n or lot number - Job Number 630046 through 630119
W202116892382 (triple collection); W202117805310 (double collection)