Recalling Firm
Philips Electronics North America Corporation
American National Red Cross, Penn Jersey Region
The American National Red Cross - Southern Region

Address2
College Business & Technology Park; Blanchardstown Road North

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

Distribution Pattern
US Nationwide Distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH NJ, NY, OH, OK, PA, TN, NX, UT, VA, VT, WA, WV
Domestic: IL, WI Foreign: None VA/DOD: None
1067 US customers 163 Canada, 917 International
Distributed domestically to AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, WI. Distributed internationally to Belgium, France, Germany, Italy, Japan, Netherlands, Spain, Sweden, United Kingdom.
The product was distributed thru out the United States. AL, AR, CA, CT, FL, GA, PA, OH, NJ, NY,IA, ID, IL, SC, MD, MT, IN, NH, MI, NC, MN, SD, WA, VA,
Product was distributed nationwide in the USA.
AK, AL, AR, AZ, CA , CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico Worldwide
US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US
Product was shipped to CA, MN, OH, TX & WA.
U.S. distribution to the following: NY, CA Foreign distribution to the following: Canada
U.S. distribution to the following: CA., WA, TX, CO, HI, IL. No foreign distribution.
Worldwide Distribution -- US, Argentina, China, Republic of Korea, Russian Federation, Slovakia, Turkey, and United Kingdom. 4 in US, (1 military), 14 foreign accounts
CA, IL, CO, TX, WA, MA, FL, PA, WA, OR, OH,
Sold to distributors in: MA, IL, CA, PR, CA, FL, MN, IL, OH, CT, MI, MO. Product was distributed nationwide including Puerto Rico.
Product was distributed to S.E. Meats in Birmingham, AL.
US Distribution and Internationally to Mexico.
CA, VA, TN, LA, MD, GA, TX, KY, NC, WA, CO, IL, PA, WI, AZ, SC, UT, MI, MA, NY, MO, NJ, WV, OR, KS, IN, RI, OH, MA, IN, NM, ID, TN, NE, NV, FL, NY,
US Nationwide Distribution - FL, WA, AZ, TN, MD, TX, FL, MI, Washington D.C.

Product Description
Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo System.
Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administration of Virazole (ribavirin) aerosol. Driven by a pressurized gas (air or blended oxygen) and uses a nebulizer to generate a fine aerosol of hydrated Virazole. --- CDRH Classification Name: Nebulizer (Direct Patient Interface)
Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.
Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1001-85, Manufactured by PharmaTech LLC, Davie, FL
Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby Laboratories 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 USA --- NDC: 0536-1025-47, Manufactured by PharmaTech LLC, Davie FL
Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 --- NDC 0536-1000-59 ; ALSO LABELED AS Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (237 mL) plastic bottles, Dist. by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152 USA. NDC: 00904-6289-09; Manufactured by PharmaTech LLC, Davie, FL
Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: Rugby Laboratories, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 --- NDC: 0536-0590-85, Manufactured by PharmaTech LLC, Davie, FL
Unifine Pentips 5mm x 31G pen needles, packaged in 30 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
Unifine Pentips 5mm x 31G pen needles, packaged in 100 ct pen needles. Product Usage: Sterile, non-toxic, non-pyrogenic, single use pen needles for the subcutaneous injection of drugs from pen injectors.
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF TRY-PS-45 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF TRY-PS-45 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF TRY-PS-45 18-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF TRY-PS-45 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF TRY-PS-40 16-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packaged in a) 5-count cartons, NDC 71030-0003-10 and NDC 71030-0003-20, and b) 25-count cartons, NDC 71030-0003-21 and NDC 71030-0003-12, Rx Only, PharMEDium Services, LLC, 913 N. Davis Ave, Cleveland, MS, Code 2R3304.
Jalebi, .5-1 lb. Clear Plastic clamshell containers
Gur Para 1 lb. clear plastic clamshell containers.
Badusha, 1 lb. clear plastic clamshell containers.
Besan Burfi, 1 lb. clear plastic clamshell containers.
Namak Para 1 lb. clear plastic clamshell containers.
Mixed Sweets- variety 1 lb. clear plastic clamshell containers.
Besan Ladoo, 1 lb. clear plastic clamshell containers.
Laddu, 1 lb. clear plastic clamshell containers.
Sakkar Para, 1 lb. clear plastic clamshell containers.
Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland, MS, NDC 71019-263-20
ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014
A&W All American Food Papa Sauce; 8/24 OZ. Pouches; Net Wt 12 LB. Paced Exclusively For Use By: A&W and its franchisees., Lexington, KY 40611; Use by: 04 29 18 and 04 30 18;
plastic cup with foil seal: House Recipe Ranch Dressing & Dip; Distributed by: Sysco Corporation, Houston, Texas 77077; Net Wt 1.5 OZ.Code: B10127; packed in cardboard case : House Recipe; Distributed By Sysco Corporation; Houston Texas 77077; B10127; HR Rch 128/1.5 oz; 3060371; 20793SYS;
Gordon Choice Honey Mustard Dressing; Net Contents 128 FL OZ; For Distribution Exclusively For Gordon Food Service, Wyoming, MI 49509 ; Code: 33217.; Honey Mustard Dressing; Keep refrigerated; Net Content 1 Gallon; Ventura Foods, Brea, CA 92821, dtd: 053018; Sysco Reliance Honey Mustard Dressing Dijon; Net Contents 1 GAL; Distributed by Sysco Corporation, Houston, Texas 77077; Lot codes: B12817; Sysco Classic Dijon Style Honey Mustard Dressing & Dip; Net Contents 3.78 L; Prepared For Sysco Corporation, Toronto, Canada; Lot codes: B12817
Sysco Imperial Tartar Sauce; Net Contents 1 GAL; Distributed by Sysco Corporation, Houston, Texas 77077; Code: 12817; Classic Gourmet Dressings Select Tartar Sauce; Net Contents 1 Gal.; Ventura Foods, Brea, CA 92821; Code 05 30 18; . Culinary Secrets Deluxe Tartar Sauce; Net Contents 1 GAL; Marketed By Independent Marketing Alliance, Houston, TX 77079; Coded: 10127 ;
Sysco Imperial Glazed Hot Bacon Dressing; Net Contents 1 GAL; Distributed by Sysco Corporation, Houston, Texas 77077; Code: B12917
Single-serve plastic packet Italian Dressing; Case packing: Sysco Classic Cls Italian 500 12Gm ; 47014SYS; B13017; single-serve plastic packet: Chef's Quality Creamy Italian; Chef's Quality; 60/1.5 OZ Pouches Net Wt 5.6 LB; 16689CHQ, B33317;
Smokehouse 220 Sweet & Spicy Barbecue Sauce; Net Wt. 16 OZ.; Ventura Foods, Brea, CA 92823; Coded: 05 30 18.
Single-serve plastic pack: Newman's Own Lite Sesame Ginger; Net Wt. 1.5 OZ.; Produced exclusively for Newman's Own, Inc., Westport CT 06880 Carton: Newman's Own, Inc., Westport CT 06880; 100/1.5 OZ; Lite Sesame Ginger, code: 042918
Classic Gourmet Dressing; Country French; Net Wt 1.5 OZ.; Ventura Foods, LLC, Lot codes: 33317; Culinary Secrets Country French Dressing; Net Wt. 1.5 OZ.; Lot Codes: 04 29 18; Sysco Reliance French Style Dressing; Net Contents 1 GAL; Lot codes: B12817; Gordon Choice California-Style Red French Dressing; Net Contents 128 FL OZ; Code: B33217;Gordon Choice California-Style Red French Dressing; Net Contents 128 FL OZ; Code: B33217; Bulk single serve- foodservice Packet: French Dressing; Case: Classic Sysco; Cls French 500 12GM; B13017, 47008SYS; Classic Gourmet Dressings Bistro Creamy French, Net Contents 1 Gal; Lot Codes: B12871; Sysco Reliance French Style Dressing; Net Contents 1 GAL; Lot codes: B12817; Classic Gourmet Dressings, Select, Kahlena French-Style; Net Contents 1 Gal; Codes: B1291, B12917, B12817
plastic cup with foil seal: House Recipe Bleu Cheese Dressing & Dip; Distributed by: Sysco Corporation, Houston, Texas 77077; Net Wt 1.5 OZ.Code: B10127; packed in cardboard case : House Recipe; Distributed By Sysco Corporation; Houston Texas 77077; B10127; HR BluChs 128/1.5 oz; 3060413; 20789SYS;
Rio Pacific Foods Deluxe BBQ Sauce; 3.78 litre; Produced in the USA for Funnybones Foodservice Ltd, Hertfordshire AL7 1HW; Lot #120117
Gordon Choice Thousand Island Dressing; Net Contents 128 FL OZ; For Distribution Exclusively For Gordon Food Service, Wyoming, MI 49509 ; Code: B33217.
Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
Persona Partial Knee System, Size 8, Finishing Guide
Blood and Blood Products for Reprocessing
Apheresis Platelets, Leukocytes Reduced, Irradiated
Phadia 1000 Instrument, Article Number 12-3800-01.
Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
Spice Supreme Beef Flavored Bouillon Cubes 1.7 oz (48 g) and NET WT. 3-1/2 OZ (98 g) 25 Count
Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), Inc. Hasbrouck Heights, NJ 07604. NDC 29300-140-01
Apheresis Red Blood Cells, Leukocytes Reduced
Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R
Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022,
Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in a) 2mL, b) 15 mL and c) 50 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022. NDC 58411-256-60
Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022, NDC 58411-256-60
Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022
bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals Beauty, Inc. SF, CA 94105 USA, NDC 98132-761-01
Michelina's Fettuccine Alfredo NET WT. 8.5 oz package Frozen CONTAINS MILK, WHEAT BELLISIO FOODS, INC., DULUTH, MN 55802 UPC 7 17854 10501 9
Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10
Polly Ann Mango Ice Cream Bar 4 BARS-2.5 FL. OZ. (75mL) TOTAL 10 FL. OZ. (300mL) UPC 7 00730 28866 1
Polly Ann Green Bean Ice Cream Bar 4 BARS-2.5 FL. OZ. (75mL) TOTAL 10 FL. OZ. (300mL) UPC 7 00730 26666 9
Polly Ann Red Bean Ice Cream Bar 4 BARS-2.5 FL. OZ. (75mL) TOTAL 10 FL. OZ. (300mL) UPC 7 00730 26868 7
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: (a) Shoulder Arthroscopy Pack 89-8686.01 (b) Shoulder Arthroscopy Pack 89-8686.02 (c) Knee Arthro Pack 89-8687.01 (d) Knee Arthro Pack 89-8687.02 Product Usage: general surgical
Hanryosued (F. Dashi Anchovy) 1.5kg x pack/carton UPC 826546102745, 826546102378
Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ 07981, NDC 66993-070-30
Ingenuity Core, (Code 728321) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Brilliance 64, (Code 728231) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Brilliance iCT Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Old Fashioned Coconut Bon Bons; Net Wt. 6.5 OZ. (184g); Manufactured by Crown Candy Corporation; Confectionery product packaged in 6.5 oz. clear plastic tubs with clear plastic lids.
Old Fashioned Pecan Divinity; Net Wt. 8 OZ. (226g); Manufactured by Crown Candy Corporation; Confectionery product packaged in 8 oz. clear plastic tubs with removable clear plastic lids.
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
Coconut Tree Brand Shredded Coconut; frozen Dua Bao; Net WT. 16 oz. (454 g); Product of Vietnam; UPC 05216-44081 Ingredient: Coconut Manufactured by: Lucky Shing Co., LTD 108/1 Road No. 830, Hamlet No. 3 An Thanh Village, Ben Luc District Long An Province, Vietnam.
Chocolate Covered Vanilla Ice Cream Bars packaged under the following brands: 12 packs - Ahold UPC: 6 88267 03323 5 and different ICB: 6 88267 08587 1, Econo UPC: 7 08938 00534 9, First Street UPC: 0 41512 11933 0, Food Club UPC: 0 36800 78404 8, Giant Eagle UPC: 0 30034 00329 6, Great Value UPC: 0 78742 09158 7, Greens UPC: 0 71441 03131 1, Hagan no ICBs, Hood UPC: 0 44100 23704 1, Kroger UPC: 0 11110 57120 5 and Kroger NFA ICBs UPC: 0 11110 57885 3, Lucerne UPC: 0 21130 09799 9, Market Basket UPC: 0 49705 96902 1, Party Treat No ICBs, PIC no product of ours, Polar Express Only Variety pack, Price Chopper UPC: 0 41735 09260 1, Price Rite UPC: 0 41190 75712 1, Purple Cow UPC: 7 08820 42754 9, Shoprite UPC: 0 41190 40126 0, Southern Home UPC: 6 07880 01147 0, , Stater UPC: 0 74175 85045 6, Stoneridge UPC: 0 41130 61333 3, Sundae Shoppe UPC: 0 41498 17991 5, Tops UPC: 0 70784 04912 0, United Dairy UPC: 0 71580 08079 9, Weis UPC: 0 41497 01042 4, Wellsley Farms Only Variety pack, Winn Dixie UPC: 0 21140 27145 7, World s Fair UPC: 0 51933 67170 6
Ice Cream Variety Packs containing Sandwiches, Bars, and Cones, Sold under the following: 30 pack - pics BY PRICE CHOPPER - UPC: 041735080295; STARTER BROS Ice Cream Favorites Variety Pack, UPC: 074175850111; WELLSLEY FARMS ICE CREAM TREATS VARIETY PACK, UPC: 888670020487; STONE RIDGE CREAMERY CLASSIC VARIETY PACK, UPC: 041130614330; POLAR EXPRESS ICE CREAM COMPANY Variety Pack, UPC: 071632613692; GIANT EAGLE Variety Pack, UPC: 030034065676; Food Club VARIETY PACK, UPC: 036800415249; FIRST STREET Ice Cream Variety Pack, UPC: 041512138690 and 32 pack - weis quality ice cream variety pack, UPC: 041497010554
Orange Cream Ice Cream Bars sold under the following labels: Sold in a 12-pack: Ahold UPC: 6 88267 03292 9, Econo UPC: 7 08938 00610 0, First Street no OCB s, Food Club UPC: 7 08938 00610 0, Giant Eagle UPC: 0 30034 00337 1, Great Value no OCB s, Greens UPC: 0 71441 03130 4, Hagan UPC: 0 37498 01609 1, Hood UPC: 0 44100 23138 4, Kemps UPC: 0 41483 03806 7, Kroger UPC: 0 11110 57028 4, Lucerne UPC: 0 21130 09796 8, Market Basket UPC: 0 49705 96901 4, PIC - no product of ours, Polar Express Only Variety pack, Price Rite UOPC: 0 41190 75722 0, Price Chopper UPC: 0 41735 09372 1, Purple Cow UPC: 7 08820 42753 2, Shoprite UPC: 0 41190 40125 3, Southern Home UPC: 6 07880 01142 5, Stater UPC: 0 74175 85013 5, Stoneridge UPC: 0 41130 61419 4, Sundae Shoppe UPC: 0 41498 8642 5, Tops UPC: 0 70784 04916 8, United Dairy UPS: 0 71580 08092 8, Weis UPC: 0 41497 01108 7, Wellsley Farms Only Variety pack, Winn Dixie no OCB s, Worlds Fair UPC: 0 51933 06140 8 and sold in a 3 pack - Party Treat UPC: 0 71632 00235 9
RASPBERRY Cream Ice Cream Bars: Sundae SHOPPE, 12 Bars, UPC 041498204631
Seasoning Blend- S.E. Meats (Diced red peppers, green peppers, celery and onions) Net weight 1300 LB in TOTE (Plastic liner, corrugated totes)
ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
Aspire HD Plus (FDR MS-2500), also known as Aspire HD Plus F and Aspire HD-s (FDR MS-2000), also known as Aspire HD Plus S). Mammography machine The Fujifilm Digital Mammography Systems, Aspire HD Plus (FDR MS-2500) and Aspire HD-s (FDR MS-2000), generate full-field digital mammography images that can, as other fall-field digital mammography systems, be used for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
Frozen Tuna Fillet Saku (Restaurant Supply Only); 22 lbs./2 x 5 kgs. Wild caught: Handline with Hook. Keep Frozen - 18 degrees C or below Product of Indonesia; Packed for H.I.G. Corporation. Carson, CA
RayStation Product Usage: is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35.

Product Quantity
Gordon: 52, 4 - 1 gal/cs.; Ventura: 192, 4-1 gal/cs. Reliance: 15, 2-1 gal/cs.; Classic: 15, 2-3.78L/cs.
Imperial: 110, 4-1 gal/cs.; Classic Gourmet: 15, 4-1 gal/cs; Culinary Secrets: 6, 4 -1 gal/cs.
455 cs/12/8.5 oz packages - total: 5460 entrees
32,028 lbs in 1300 LB in TOTE (Plastic liner, corrugated totes)

Reason for Recall
Power Strip and TrippLite Power Strip due to overheat of input resistor causing the power strip to smoke.
Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
Device may potentially be compromised by water in end user packaging. Exposure to liquid may compromise sterility. This may appear as discoloring or yellowing of the device's protective seal.
Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.
New Punjab Sweets, Inc.is initiating a voluntary recall of multiple products due to undeclared allergens wheat and milk.
On the HeartStart XL+, EFT noise can disable ECG monitoring and potentially interrupt demand mode pacing*. *Note: It is contrary to the XL+ Instructions for Use to perform demand mode pacing while using the ECG out cable or obtaining the ECG signal from a bedside monitor. The XL+ Instructions for Use includes the following warning: When pacing in Demand Mode, the ECG cable from the patient must be directly connected to the HeartStart XL+. If the user follows this warning, this problem cannot occur on the XL+.
A plastic foreign object was inadvertently introduced into the product stream. The firm is recalling product as not all plastic has been accounted.
Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack.
Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion.
Blood product, in which donor suitability was not adequately determined, was distributed.
Apheresis products for which white blood cell count testing was not performed, were distributed.
Raplixa Delivery Kit, not meeting labeling claims, were distributed.
command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitation.
Gel Spice, Inc. is recalling three beef flavored bouillon cube products because they contain undeclared allergens -- soy and wheat.
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Apheresis products for which quality control procedures were not performed, were distributed.
Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Platelet products, in which platelet yield did not meet specifications, were distributed.
Undeclared soy. Firm was notified by a consumer that they found chicken in the product. The chicken contains soy.
1 IFU was missing pages 15 - 62 While pages 27 50, 75 76, and 15 62 contain instructions written in a language other than English, pages 1 2 contain information regarding the indications for use, contraindications, device description, warning and precautions, and potential complications of the device.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Presence of foreign substance: metallic razor blade was found in one bottle.
DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.
Un-eviscerated and/or partially eviscerated dried fish.
Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
An intermittent ingredient statement labeling error by the firm's label printing company led to the firm's Pecan Divinity products being mislabeled with the ingredients for its Coconut Bon Bon products. Also, the firm's Coconut Bon Bon products were intermittently mislabeled with the ingredients for the firm's Pecan Divinity products. The intermittent labeling errors led to the undeclared allergen of pecans in the ingredient statement of the Pecan Divinity products and the undeclared allergen of coconut in ingredient statement of the Coconut Bon Bon products.
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
State of Massachusetts tested product and found it to be positive for Salmonella
Product may be contaminated with Listeria monocytogenes.
The product has been recalled because it has the potential to be contaminated with a chemical pesticide residue.
There was a case that the swivel arm went down unintentionally when it was moved up/down.
Customer tested product and found Listeria monocytogenes in frozen tuna fillet saku
For the proton QA preparation module in RayStation 6 (including SP1 and SP2), if the snout position or gap is modified in the QA module, the dose in the QA module may be computed for a different setup than what is used for QA measurements. This could result in an incorrect dosage being provided to a patient.
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
Labeling: Not Elsewhere Classified: Mitomycin 40 mg/10 mL labeled incorrectly as Mitomycin 40 mg/mL.

Code Info
Part Number 04175-0008 and Part Number 13-00106-00
Lot Number J0571670RA*/Serial Number 337170600007; Lot Number J0571670R*/Serial Number 337170600007; Lot Number J0571670/Serial Number 337170600007; Lot Number L0197340/Serial Number 340150600003; Lot Number K1900650/Serial Number 340150600003.
No codes are available; no lot numbers, no expiration dates
M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641
Imperial: Code: 12817; lot date 11/28/2017 Classic Gourmet: Code 05 30 18; Culinary Secrets: Coded: 10127; lot date 12/1/2017
Product Codes: DEMOPF009, PF009, SAPF009
CM1517, CM1617, CM1717, CM1817, CM1917, CM2017, CO2117, CM2217, CM2317, and CM2417. The codes are interpreted as: CM = Chum Salmon CO = Coho Salmon first and second digit = sequential batch number of the year. third and fourth digit = calendar year 2017.
Model's; L210, L211, and L231 - NOT APPROVED IN US
PRODUCT IDENTIFICATION CODE J7305D16 BEST BY 01NOV2018
UPC Code 041466031238 Lot numbers: 11577 Expiration Date 2/06/18; 11917 Expiration Date 3/10/18; 12597 Expiration Date 5/16/18; 12777 Expiration Date 6/04/18; 12987 Expiration Date 6/25/18; and 13187 Expiration Date 7/14/18
UPC Code 041466031207; Lot number 13007 with Expiration Date 3/27/18; and Lot number 13327 Expiration with Date 4/28/18
All lots, item number 331233 Affected lot number is SE07A1; however that number is only on the outer case and not on individual bags.
The recalled products have a production date of January 1, 2017 to December 31, 2017 and a best by date of January 1, 2018 to December 31, 2018. The Hood and Kemps products may show a best by date of July 1, 2018 to June 30, 2019.
The recalled products have a production date of May 2017 to August 2017 and a best by date of May 2018 to August 2018.
FDR MS-2500 made in Japan : S/N- 16640001 or later FDR MS-2500 made in China : S/N- 26860001 or later FDR MS-2000 made in Japan : S/N- 16650001 or later FDR MS-2000 made in China : S/N- 26870001 or later