Recalling Firm
Del Monte Fresh Produce North America, Inc

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

Distribution Pattern
Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.
US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee.
Product distributed to AZ, CA, CO, ID, MT, NV, NM, OR, UT and Canada
Nationwide Distribution including FL, IL, TN, GA, VA, MO, NM, WI, MI, NC, IN, OH, MA, CA, WA, PA, KY, MD, HI, and AL.
Worldwide Distribution - US Nationwide in all states in continental USA including DC, PR, GU, and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR,K ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALTA, MARTINIQUE, MAURITIUS, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE , UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM, ZAMBIA.
AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI CANADA, CHINA, ISRAEL, and LATVIA
US Distribution in the state of Maryland.
Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, India, Israel, Italy, Japan, Lebanon, Mexico, Monaco, Netherlands, Pakistan, Panama, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and the United Kingdom.
Product was distributed in Utah and Idaho. No military/govt/VA or foreign consignees
Worldwide Distribution - Nationwide Distribution and VA/military/govt consignees and the country of Canada.
Nationwide Distribution- including the states of CA, MI, NY, IL, NH, KS, NY, UT, IA, WI, TX, and FL.
Worldwide Distribution -- US, Canada, Czech Republic, Denmark, Great Britain, and Sweden.
AR, CO, FL, GA, IA, IL, IN, KY, LA, NC, NJ, OH, PA, SC, TN, TX & VA.
Nationwide to all US states. 1 foreign distribution to Estonia. No govt/VA/military.
Downloaded by Apple users - locations not shared by Apple.
Nationwide Distribution-including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii.
Distributed in the states of VA and TX and the country of Japan.
US (nationwide) including the states of AR, CA, CO, CT, FL, IA, IL, KS, KY, MD, MI, MO, MS, NY, OH, PA, TX, UT, WA, and WI and the country of Japan.

Product Description
LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers, Rx Only, Hospira, Inc., Lake Forest, IL 600045, NDC 0409-7929-09
1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Free glass vial (Twenty-five (25) units per box/fifty (50) units per case, NDC 0409-4279-02, Hospira, Inc., Lake Forest, IL 60045
Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4332-01.
Ketorolac Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Single-dose Fliptop Vial, packaged in 25 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-3796-01.
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-6533-01.
Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis.
Caramel Apples packaged in the following configurations with Best By date range - 8/25-11/23/2014, Responsible firm name on label is Happy Apple Inc., Washington, MO., and Orosi, CA.,: Happy Apples Simply Caramel Value 3 Pack, Net Wt. 9 oz., Happy Apples Simply Caramel 4 Pack, Net Wt. 14 oz., Happy Apples Simply Double Caramel Value 3 Pack, Net Wt. 11.25 oz., Happy Apples Double Caramel, Net Wt. 3.75 oz., Happy Apples Simply Caramel Net Wt. 3.5oz., and Kroger, Simply Caramel, 3 Apples, Net Wt. 9 oz., with Best By date range - 9/15-11/18/2014,
Caramel Apple Topped with Chocolate & Peanuts with Best By Date range - 8/25-11/23/2014, Responsible firm name on label is Happy Apple Inc., Washington, MO., and Orosi, CA., packaged in the following configurations: Happy Apples Select 3 Pack, Net Wt. 12 oz., Happy Apples Select, Net Wt. 4 oz., Grand Gourmet, Net Wt. 11 oz.
Happy Apples Crunch Topping Caramel Apples, Net Wt. 3.5 oz., with Best By date range - 8/25-11/23/2014, Responsible firm name on label is Happy Apple Inc., Washington, MO., and Orosi, CA.
Caramel Apples with Peanuts, with Best By date range - 8/25-11/23/2014, Responsible firm name on label is Happy Apple Inc., Washington, MO., and Orosi, CA., packaged in the following configurations: Happy Apples, Net Wt. 3.75 oz., Happy Apples 3 Pack, Net Wt. 9 oz., Happy Apples 4 Pack, Net Wt. 16 oz., Happy Apples 8 Pack, Net Wt. 24 oz., and Kroger 3 Apples, Net Wt. 10.5 oz., with Best By date range - 9/15-11/18/2014 and Kroger 1 Apple, Net Wt. 3.5 oz., with Best By date range - 9/15-11/18/2014.
Caramel Apple packaged topped with colored sprinkles packaged in the following configurations with Best By Date range - 8/25-11/23/2014, Responsible firm name on label is Happy Apple Inc., Washington, MO., and Oro si, CA.,: Happy Apples Wacky, Net Wt. 3.75 oz., Happy Apples Spooky Sprinkles, Net Wt. 3.75 oz., Kroger with Sprinkles, 3 Apples, Net Wt. 10.5 oz, Kroger with Sprinkles, 1 Apple, Net Wt. 3.5 oz.
Caramel Apples with red cinnamon, topped with peanuts packaged in the following configurations with Best By Date range - 8/25-11/23/2014, Responsible firm name on label is appy Apple Inc., Washington, MO, and Orosi, CA, : Happy Apples, 1 Apple, Net Wt. 3.75 oz., Happy Apples, Value 3 Pack, Net Wt. 9 oz., Happy Apples, 4 Pack, Net Wt. 15 os., K roger Candy Apples, Net Wt. 3.75 oz. with Best By Date range - 9/15-11/18/2014, and Kroger Candy Apples 3 Pack, Net Wt. 10.5 oz. with Best By Date range - 9/15 -11/18/2014.
Happy Apples Grand Gourmet Pecan Caramel Apple packaged in the following configurations with Best By Date range - 8/25-11/23/2014, Responsible firm name on label is Happy Apple Inc., Washington, MO., and Oro si, CA.,: Grand Gourmet, Net WT. 11 oz. and
Happy Apples Cinnamon Crunch Caramel Apple, Net Wt. 3.5 oz., with Best By Date range - 8/25-11/23/2014, Responsible firm name on label is Happy Apple Inc., Washington, MO., and Orosi, CA.
RSCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicated for airway management. The product may be used to reduce the potential for kinking whenever an unusual positioning of the head or neck is required following intubation.
Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.
This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa Excite 1.5T HD Highspeed, 1.5T Signa Infinity TwinSpeed , 1.5T Signa Infinity EchoSpeed Plus, 1.5T Signa Infinity HiSpeed Plus, 1.0T Signa Infinity HiSpeed Plus. 1.0T Signa Infinity SmartSpeed, Signa EXCITE 3.0T, Signa EXCITE 3.0T HD, Signa Excite 1.5T TwinSpeed, Signa Excite 1.5T EchoSpeed, Signa Excite 1.5T HiSpeed, Signa Excite 1.5T SmartSpeed, Signa Excite 1.5T, Signa Excite 3.0T, Signa Contour/I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w. Product Usage: Magnetic resonance (MR) diagnostic devices are intended for producing images of the internal structures of the body based on the spatial distribution of molecules exhibiting magnetic resonance. Most MR systems are intended for diagnostic use.
SOGEVAL Medicated Shampoo Antibacterial and Anti Fungal in 16 fl. oz.
VET ONE Medicated Shampoo Veterinary Formula Antibacterial and Antifungal in 16 fl. oz.
VET SELECTION Universal Medicated Shampoo for Dogs and Cats in 8 or 16 fl. oz.
Dr. SKIN MediSeb Shampoo All Purpose, Antiseborrheic, Antimicrobial, Cleansing Formulation in 8 fl. oz.
TALGAL PRO Medicated Shampoo Antibacterial, Antifungal in 16 fl.oz.
VHS Veterinary Healthcare Solutions Medicated Shampoo Antibacterial Antifungal for dogs, cats, and horses in 16 fl.oz.
DOC WATSON'S REMEDIES Salon Medicated Shampoo Antibacterial Antifungal in 16 fl.oz
Red Blood Cells Leukocytes Reduced Irradiated
Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
7-Eleven FRESH TO GO Fruit Mania 6 ounce UPC 0-52548-51982-7; No brand name sold at Circle K stores Fruit Mania 6 ounce UPC 7-17524-77638-9
7-Eleven FRESH TO GO Harvest Blend 4 ounces UPC: 0-52548-55825-3
7-Eleven Green Apple Slices 8 ounces UPC: 0-52548-52481-4; Del Monte Green Apple Slices 12 ounces UPC: 7-17524-71909-6
Del Monte Snack Pack Apple Slices w. Litehouse Caramel Dip 5 ounces UPC: 7-17524-71943-0
Del Monte Snack Pack Apple Slices w. Grapes & Cheese Litehouse Caramel Dip 7 ounces UPC: 7-17524-77394-4
Del Monte Apple Slices 10 ounces UPC: 7-17524-72093-1
HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System
HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System
Condies Foods, Bold & Zesty Salsa, 14 oz, UPC: 05077744220
Dr. J's Smart Gourmet Salsa Mild , 15 oz., UPC: 793573078148
Dr. J's Smart Gourmet SalsaMedium, 15 oz., UPC: 793573939166 (Medium).
Mint Bar, refrigerated, single slice wrapped in cellophane, net wt. 8 oz. The product's label read in parts: ''***my sweet ol' etcetera bakery***Mint Bar***Ingredients org flour, org. egg, butter (milk), chocolate, sugar, vanilla, peppermint oil, powdered sugar, butter (milk), cream, melted chocolate***8 oz.***250 oak st. Ashland***541-622-9539***''.
Peanut Butter Brownie, refrigerated, single slice wrapped in cellophane, net wt. 8 oz. The product's label read in parts: ''***New item My sweet ol' etcetera bakery***Peanut Butter brownie, org wheat flour, org. egg, butter, vanilla, sugar, unsw chocolate, Buttercream natural peanut butter, butter (milk), pwd sugar cream, chocolate***8 oz.***250 oak st.#2 Ashland***541-622-9539***''.
MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.
Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.
Gastroade Xtra (Omeprazole) paste, Net Contents 32 ml, Cox Cox Veterinary Laboratory, Inc., 1865 Pressley Rd., Chester, SC 29706.
PROBAR Frosted Peanut Butter BASE Protein Bar, 2.46 oz film wrapped bar packaged in 12 wrapped units per sleeve/carton. Unit UPC:8-53152-10060-5. 12 count box UPC: 8-53152-10061-2.
Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operating system, intended to be used with the AliveCor Heart Monitor. The AliveCor Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation and normal sinus rhythm (when prescribed or used under the care of a physician).
Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
Haitai Tayo Crackers, 140 g, 24 boxes/carton, in box colors: blue, yellow, and red.
Haitai Gyeran Crackers, 70 g, 20 boxes/carton, in yellow box with ''Angry Birds'' logo.
Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component
Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.

Code Info
One shipment of Lot #: 34-366-8E02; Exp 1OCT2015 to The Harvard Drug Group, Livonia, MI
One shipment of Lot #: 34-540-DK; Exp 1OCT2015 to The Harvard Drug Group, Livonia, MI
One shipment of Lot #: 33-750-DJ; Exp 1SEP2015 to The Harvard Drug Group, Livonia, MI
Model Number PV8810US; Lot # 14AK20 and 14EK20
Model: Catalog #CT -99 Part number: 50137 Lot number(s): 13380, 13390 and 13418.
Serial numbers: D-ESP-1001 and D-ESP-1003
All product with USA36A4.4 version of software affected
Model Number 10848600, serial number 82010
Lot numbers: HMO 9200 HMO 9217 HMO 9226 HMO 9232 HMO 9276 HMO 9285 HMO 9292 Exp. Date 1/2017
Catalog Number: 13-104150 Lot Number Identification: 364600
Catalog Number: 16-104152 Lot Number Identification: 427840
HX2 Temperature Management System, 120V Catalog # 809810 serial numbers: 00016, 0001 1116 HX2 Temperature Management System, 100V Catalog # 812231 serial numbers: 0001, 1002, PT0003, PT0004 HX2 Temperature Management System, 240V Catalog # 812240 serial numbers: 0001, 0002 HX2 Temperature Management System, Trial Kit Catalog # 809810TK serial numbers: 1001 1042

Product Quantity
single apple pkg - 131/48 count/cases, 3,787/24 count/cases, 2,218/12 count cases and triple apple pkg - 5,047/12 count/cases, 428/6 count/cases
single apple package - 10/48 count/cases, 1,836/24 count/cases, 8,510/12 count cases, 166/12 count cases
single apple package - 5/48 count/cases, 4,633/24 count /cases, 84/12 count/cases
single apple pkg - 152/48 count/cases, 24,628/24 count/cases, 3,264/12 count/cases and triple apple pkg - 14,653/12 count cases, 434/6 count/cases
single apple package - 123/48 count/cases, 6,466/24 count/cases, 472/12 count/cases and triple apple pkg - 480/12 count/cases
single apple package - 123/48 count/cases, 8,206/24 count/cases, 112/12 count/cases, and triple apple package - 6,180/12 count/cases
single apple package - 188/12 count/cases
single apple package - 2,334/24 count/cases, 14/12 count cases
5600 active users with Alive ECG app for iOS .

Reason for Recall
Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of the primary container, consistent with mold.
Presence of particulate matter: A returned customer sample was evaluated and found to have human hair attached to a pinched area of the stopper.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Internal testing and investigation of the packaging revealed cracks and holes in primary packaging
CDC epidemiologists have linked an outbreak of Listeria monocytogenes illness to caramel apples.
Teleflex Medical has issued an advisory notification for the RSCH Curved Reinforced Endotracheal Tube because of a discrepancy between the labeled cuff diameter and the actual cuff diameter. The actual product cuff diameter meets required specification.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Blood product, which did not meet the acceptable product specifications for release, was distributed.
Blood product, positive for the K-antigen but labeled as K-antigen negative, was distributed.
Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.
At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.
Labeling discrepancy listing the active ingredient, Chloroxylenol as 2% when the actual concentration is 0.25%.
Blood products, which did not meet acceptable product specifications, were distributed.
Blood product, which was labeled with an incorrect expiration date, was distributed.
The MRI system safety feature, which lowers the magnetic field in emergency situations, may not work correctly.
Product may be contaminated with Listeria monocytogenes
Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.
Condies Foods, Inc. is recalling Condies brand Bold and Zesty salsa and Dr. Js brand Mild and Medium salsas because they contain the recalled spice cumin, which may contain undeclared peanut protein.
Condies Foods, Inc. is recalling Condies brand Bold and Zesty salsa and Dr. J's brand Mild and Medium salsas because they contain the recalled spice cumin, which may contain undeclared peanut protein.
Mint Bar is recalled due to undeclared wheat and soy lecithin
Peanut Butter Brownie is recalled due to undeclared soy lecithin.
CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery.
The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself.
The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.
Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter.
Product is an unapproved new animal drug.
PROBAR, LLC has initiated a voluntary recall of its PROBAR Base Frosted Peanut Butter Bars due the possible presence of an undeclared milk allergen.
Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon use of the application.
When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated
Hamchorom is recalling Tayo and Gyeran Crackers because they contain undeclared milk and eggs.
Biomet voluntarily recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.
Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and shows error messages EOd (invalid mix valve measured range of motion) or EOE (valve unable to move or complete a motion). Mixing valves need to be replaced at regular intervals.