Recalling Firm
Valeant Pharmaceuticals North America LLC
St Mary's Hospital and Medical Center, Inc.
Taylor Farms Pacific Inc. (MacArthur Facility)

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

Distribution Pattern
AL , AR , AZ , BC , CA , CO , CT , FL , GA , IA , IL , IN , KS , KY , LA , MA , MD , MI , MN , MO , MT , NC, NE , NH, NJ , NM , NV , NY , OH , OK, ON , OR, PA , SC , TX , VA , WA , WI, WV, and WY. Worldwide: SINGAPORE, SHAU KEI WAN HONG KONG, SANTIAGO,CIUDAD DE MEXICO, and SHIZUOKA-KEN JAPAN.
Distributon was made to AL, AR, AZ, CA, CO, FL, GA, KS, LA, MO, MS, NV, OK. OR, SC, SD, TN, TX, UT and WA. No foreign or military distribution was made.
The product was distributed to one company in Schertz, TX.
US Nationwide Distribution in the states of CA, FL, IN, MD, NC, NH, NY, OH, PA and WI.
Nationwide distribution. No product was distributed to foreign, military, or government facilities.
US: Nationwide (AL, AR, CA, CA, FL, GA, IL, IN, KS, MI, NC, NJ, OH, OK, TN, TX, VA)
distributed in Spokane area of Washington.
Nationwide Distribution including Puerto Rico and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, ME, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA and WI.
Worldwide Distribution - US including the states of CA, GA, MI, NJ, NV, and TX., and the countries of: Austria, Finland, Germany, Poland, Singapore, Sweden, Switzerland and United Kingdom.
Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.
Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, China, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
*** US: Nationwide (CA, GA, IL, MS, NC, TX); *** FOREIGN: Australia, Belgium, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, India, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, Norway, Poland, Qatar, Russia, South Korea, Singapore, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam
US Distribution including the states of MD, NC , LA , IN , OH, KY, CA , PA , NY and NV.
Worldwide Distribution - US Nationwide and the countries of : Argentina, Australia, Canada, Chile, France, Germany, Hungary, Iceland, Italy, Lithuania, Mexico, New Zealand, Romania, Russia, South Africa, Sweden, and Yemen.
Worldwide Distribution - US Nationwide in the state of SD, OH, CT and the country of: The Netherlands and India.
Worldwide Distribution-USA (nationwide) including the states of CA, DE, FL, GA, IL, IN, KS, KY, MA, MN,MS, NC, NM, NV, NY, OH, PA, TN, TX, and VA, and the country of Canada.
The affected product was distributed to Mexico, Turkey, and United Arab Emirates only. The affected product was not distributed to the US.

Product Description
HIGH PROTEIN MONKEY DIET REGRIND MEAL 50 LB
HIGH PROTEIN MONKEY DIET REGRIND MEAL 25 LB
MAZURI CALLITRICHID HIGH FIBER DIET SIZE VARIES
ADVANCED PROTOCOL OLD WORLD PRIMATE WITH DENTAGUARD 25 LB
MAZURI CALLITRIC GEL DIET, NO SUGAR ADDED (BAG SIZE VARIES)
ADVANCED PROTOCOL SMALL AVIAN DIET 11 LB
MAZ MINIPACK KOI PLATINUM WHEAT NUGGETS 2.5 LB
MAZURI BZ CALLITRICHID DIET (BAG SIZE VARIES)
GRAIN-BASED NON-HUMAN PRIMATE TABLET 1 GM BANANA (BAG SIZE VARIES)
GRAIN-BASED NON-HUMAN PRIMATE TABLET 190 MG FRUIT PUNCH (BAG SIZE VARIES)
GRAIN-BASED NON-HUMAN PRIMATE TABLET 45 MG RASPBERRY (BAG SIZE VARIES)
GRAIN-BASED NON-HUMAN PRIMATE TABLET 97 MG RASPBERRY (BAG SIZE VARIES)
GRAIN-BASED NON-HUMAN PRIMATE TABALET 97 MG GRAPE (BAG SIZE VARIES)
GRAIN-BASED NON-HUMAN PRIMATE TABLET 97 MG FRUIT PUNCH (BAG SIZE VARIES)
GRAIN-BASED NON-HUMAN PRIMATE TABLET 1 GM FRUIT PUNCH (BAG SIZE VARIES)
MAZURI CALLITRICHID GEL DIET, HIGH VITAMIN D (BAG SIZE VARIES)
LABDIET 5025W/0.5%CHOLESTEROL FROM EGGS/5%LARD (BAG SIZE VARIES)
Purina ONE beyond, White Meat Chicken & Barley, dry dog food, packaged in a 3.5 lb bag. UPC 1780012679.
Vaseretic (enalapril maleate/hydrochlorothiazide) 10/25 mg Tablets, NDC 0187-0146-01, 100 ct. bottles manufactured at Valeant Pharmaceuticals International, Inc., Steinbach, MD R5G 1Z7 Canada
Ham & Cheddar Sandwiches, 10.5 oz . The sandwiches are wrapped in plastic and then placed in a clear plastic clamshell.
Turkey & Swiss Sandwiches, 10.5 oz . The sandwiches are wrapped in plastic and then placed in a clear plastic clamshell.
Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Single-Dose Vial, Rx only, For Infiltration and Nerve Block including Epidural and Caudal, Manufactured by: Hospira, Inc., Lake Forest, IL, 60045, NDC 0409-2066-05
Atorvastatin Calcium 40 MG Tablet, MFG: Apotex NDC# 6050525808
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood and Blood Products for Reprocessing
Platelets Pheresis Leukocytes Reduced Irradiated
Shell Eggs packaged under the following labels: (1) Abbotsford Farms Cage Free Pasteurized Shell Eggs, Grade A Large Brown Eggs, packaged as 15 dozen per 1 case. Distributed by Abbotsford Farms, Gaylord, MN 55334. UPC Code 1 00 14616 64010 7. (2) AbbotsFord Farms Cage Free 1 Dozen Large Eggs Pasteurized for Safety. The product was packaged as 1 case of 15 1-dozen eggs per carton. Distributed by Abbotsford Farms, Gaylord, MN 55334. UPC Code 1 00 14616 64010 6. (3) Pepetti's Pasteurized Shell Eggs made with Grade A Large White Eggs, packaged as 15 dozen per 1 case. Distributed by: Michael Foods, Inc., Minnetonka, MN 55305. UPC Code 1 07 46025 86990 7. (4) Glenview Farms Pasteurized Shell Eggs made with Grade A Large White Eggs, packaged as 15 dozen per 1 case. Distributed by U.S. Foodservice Inc., Rosemount, IL 60018. UPC Code 5 07 58108 62234 5. (5) Crystal Farms One Dozen Large Eggs, Pasteurized Eggs. The product was packaged as 1 case of 15 1-dozen eggs per carton. Distributed by Crystal Farms, Lake Mills, WI 53551-0753. UPC Code 1 00 75925 00032 6. (6) GFS Large Pasteurized Eggs, packaged as 15 dozen per 1 case. Distributed by Gordon Food Service, Grand Rapids, MI 49548. UPC Code 0 00 93901 26545 6.
Individually 2/3 oz. slices of American cheese product individually wrapped in transparent plastic an packaged in 12 oz. and 16 oz.. packages, and 4 lb. cartons under the Kraft brand name. Cases of 12 oz. packages include 48 packages per case. Cases of 16 oz. packages include either 12 or 36 packages per case. Cases of 4 lb. cartons include 8 cartons per case.
Tullia's Italian Meatless Pasta Sauce, packaged in a 16 oz. (436g) and 32 oz. (872g) glass jars with one-piece metal closures. The 32 oz. (872g) glass jar has the UPC 7 48863 64322 3. The 16 oz (436g) glass jar has the UPC 7 48863 64321 6.
Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
Philips Expression MR200 MRI Patient Monitoring System
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Product Code 6802445. The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.
VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084
Propranolol HCl, NET WT 1 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0004
Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01
Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002
CST Roma Tomatoes Whole Roma 1/25# Origin: USA Keep Refrigerated UPC: 40000356942 Taylor Farms, Pacific, Tracy, CA 95376
Signature Cafe SWY Sicilian Vegetable Salad 2CT Kit Pack Size: 2-6.75 lb bags S3197 Perishable Keep Refrigerated Distributed by Lucerne Foods Inc. PO Box 99 Pleasanton, CA 94566-0009 1-877-232-4271 Product is distributed to be assembled and sold at deli counters where customers request purchase amount. Roma tomatoes are shipped with the salad kit and diced at retail locations to be mixed with salad.
Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R
Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected Part Number: 22660PC
Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660
Covidien Kendall 1710H Multi-Function Defibrillation Electrodes Part Number: 40000006
MediChoice Multifunction Electrode Part Number: MC171 OH
Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A
Fresh Finds ground black pepper Net Wt. 3.53 oz (100g) Distributed by: Big Lots Stores, Inc. P.O. Box 28523 Columbus, OH 43228-0523 Packed in the USA UPC 411010982901 packaged in plastic jars; 12 jars per case
Su Cocina brand Pan Molido (Plain Bread Crumbs). Product is packaged in 8 oz. bags. The UPC is 6 79790 05912 5. The Label is read in parts: ''***SU COCINA***Plain Bread Crumbs***INGREDIENTS: Bread Crumbs*** DOMINGUEZ FOODS OF WASHINGTON*** P.O. Box 506, Zillah, Washington 98953***509-829-6089***''.
EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.
EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professional Nebulizer System is suitable for use in adult and pediatric patients. The Aeroneb Solo Nebulizer System is an iteration of the Aeroneb Professional Nebulizer System which is single patient use. The FRIWO AC/DC adapter is a component of the Aerogen Nebulizer systems which is used to power the Pro and Pro X controllers.
Multi-Lumen Central Venous Catheterization Kit
eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (including but not limited to CT,MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm Workstation can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record.
ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine.
Discovery Elbow Humeral Trial Product Usage: Biomet manufactures a variety of elbow joint replacement prostheses intended for primary and revision joint arthoplasty for use in cemented applications. Elbow joint replacement components include humeral and ulnar components, and in some instances, hinge components.
AC Powered adjustable bed frame. AC powered adjustable bed frame used in nursing facilities.
Hydrocortisone Butyrate Cream 0.1%, Net Wt. 15 gm tubes, Rx only, Manufactured for: Rouses Point Pharmaceuticals, LLC Cranford, NJ 07016 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 43478-270-15
Locoid (hydrocortisone butyrate 0.1%), Cream, Net Wt. 15 gm tubes, Rx only, Manufactured for: Onset Dermatologics, LLC, Cumberland, RI 02864 By: Ferndale Laboratories, Inc. Ferndale, MI 48220 --- NDC 16781-382-15
V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.
Kong Jumbo Aussie Sticks Beef 1 Chew, UPC 0 39897 75559 5
Kong Jumbo Aussie Sticks Lamb 1 Chew, UPC 0 39897 75560 1
Wild Caught Seared Ahi Tuna Seasoned with Cracked Black Pepper and Garlic, manufactured by Lagniappe Louisiana Foods, Inc.-Instructions say to keep frozen.
TOPIRAMATE Tablets 200 mg, 60 Tablet Bottles, Rx Only. Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ USA 08534. NDC 68382-141-14.
HYDROXYPROGESTERONE CAPROATE 250 MG/ML (IN SESAME OIL), Rx Only 4 mL INJECTABLE IM USE. Manufactured by Avella Specialty Pharmacy, Phoenix, AZ 85085.
Bumble Bee Premium Albacore Tuna in Water, Net Wt. 2.5oz, UPC 8660024011, 8660024031, 5763800424. Bumble Bee Premium Albacore Tuna In Water, Net Wt. 5oz, UPC 8660024016; UPC 8660024051, 5763800425.
Bumble Bee Prime Fillet Albacore Tuna with Jalapenos and Olive Oil, Net Wt. 2.5 oz, UPC 8660024012
Bumble Bee Prime Fillet Albacore Tuna with Sundried Tomatoes and Olive Oil, Net Wt. 2.5oz, UPC 8660024013
Bumble Bee Prime Fillet Albacore Tuna with Chipotle and Olive Oil, Net Wt. 2.5oz, UPC 8660024014
Bumble Bee Prime Fillet Omega-3 Albacore Tuna with Omega 3 Tuna Oil, Net Wt. 2.5oz, UPC 8660024191
Bumble Bee Premium Lightmeat Tuna in Water, Net Wt. 2.5oz, UPC 5763800426. Bumble Bee Premium Lightmeat Tuna in Water, Net Wt. 5oz, UPC 5763800427.
Bumble Bee Jalapeno Albacore Tuna with Jalapeno & Olive Oil, Net Wt. 2.5oz, UPC 5763800428
Bumble Bee Chipotle Albacore Tuna with Chipotle & Olive Oil, Net Wt. 2.5oz, UPC 5763800429.
Bumble Bee Sun Dried Tomato with Sun Dried Tomatoes & Olive Oil, Net Wt. 2.5oz, UPC 5763800430.
Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195

Code Info
Lot code: APR04121 Formula Item Number 50400006549
Lot code:APR09122 Formula Item Number 5045M0006551
Lot code:APR24122 Formula Item Number 5045M0006552
Lot code:MAY05121 Formula Item Number 51200006570
Lot code:APR27121 Formula Item Number 500A0007429
Lot code:2MAY11MFI3, 2MAY24MFI3, 2MAY29MFI1, 2JUN14MFI1, 2JUN21MFI3, and 2JUL06MFI1. Formula Item Number 560B0007864
Lot code:12JUN05RTD1 Formula Item Number 5MI50008107
Lot code:12JUN12RTD1, 12MAY21RTD1 Formula Item Number 5MI60008108
Lot code:MAY07122 Formula Item Number 5ME60025433
Lot code:MAY07121 Formula Item Number 51V20032876
Lot code:MAY04123 Formula Item Number 5LG10033078
Lot code:APR29122 Formula Item Number 5000M0046064
Lot code:12JUN08RTD1 Formula Item Number 592Y0047797
lot codes: APR15123, APR28123 Formula: Item number: 5LP30055545
Lot codes: APR11122, APR15123 Formula Item number 5LP50055567
Lot number: APR15122 Formula Item number 5LP60055568
Lot code:APR12122A, APR17122A Formula Item Number 50E60060296
Lot code:APR03121 Formula Item Number 5MG10062615
Lot code:BEST BY 06/04/14 AND 06/05/14 Formula Item Number 5.00E+080065162
Lot code:APR03121, APR27121, MAY07121 Formula Item Number 5MM30065236
Lot code:APR04123 Formula Item Number 5MM40065238
Lot code:12JUN14RTD1, 12MAY17RTD1, 12MAY24RTD1 Formula Item Number 5TAF1810536
Lot code:12APR26RTD1, 12JUN11RTD1, 12MAY11RTD1, 12MAY16RTD1 Formula Item Number 5TUR1811182
Lot code:12JUN15RTD1 Formula Item Number 5TUR1811441
Lot code:12JUN07RTD1 Formula Item Number 5TUR1811466
Lot code:12MAY09RTD1 Formula Item Number 5TUR1811467
Lot code:12MAY09RTD1 Formula Item Number 5TUR1811473
Lot code:12MAY09RTD1 Formula Item Number 5TUR1811479
Lot code:12JUN07RTD1 Formula Item Number 5TUR1811482
Lot code:12MAY21RDT1 Formula Item Number 5B341815098
Lot code:12APR10RTD1 Formula Item Number 9G021815113-409
Lot code:12MAY10RTD1 Formula Item Number 9G0Y1815142-209
Production Code: 31071083, Best By date: OCT 2014
1) 12 oz. packages of singles; UPC (Retail Package): 021000604647; Code Dates: 20 FEB 2015, 21 FEB 2015; UPC Code (Case): 210006046400; 2) 16 oz. packages of singles; UPC (Retail Package): 021000615261; Code Date: 20 FEB 2015; UPC Code (Case): 210006145000; 3) 16 oz. packages of singles; UPC (Retail Package): 021000615261; Code Date: 20 FEB 2015; UPC Code (Case): 210006152600; 4) 4 lb. cartons of singles; UPC (Retail Package): 021000633609; Code Date: 20 FEB 2015; UPC Code (Case): 210006255900
Software Version 3.0 and below; Serial Numbers J46000012 - J46000456 (serial numbers are sequential; J Numbers are analogous to serial numbers)
Software Version 3.0 and below; Serial Numbers J56000110 - J56001995 (serial numbers are sequential; J Numbers are analogous to serial numbers)
EndoWrist Stapler 45 instrument, Model Number: IS3000 Part Number: PN 410298-06, -07, -08, -09 All Lots.
FRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers: 1) Model Number: 1079422; Lot Numbers: 9070140620088 , 9070140723088 , 9070140723088; 2) Model Number: 1082693; Lot Numbers: 9073140618134; 3) Model Number: 1082694; Lot Numbers: 9074140530079
FRIWO AC/DC Adapter Model Number: GPP10; The FRIWO AC/DC Adapter is supplied with the following Aeroneb Nebulizer systems and their respective model numbers: 1) Model Number: AG -UC1000-NE; Lot Numbers: 9263140718116 , 9263140718137 , 9263140730049; 2) Model Number: AG-UC1000-UK; Lot Numbers: 9235140718022 , 9235140718093 , 9235140718154; 3) Model Number: AG-UC1500-NE; Lot Numbers: 9264140627057 , 9264140627100 , 9264140721112 , 9264140724100; 4) Model Number: AG-UC1500-SC; Lot Numbers: 9277140721040; 5) Model Number: AG-UC1500-SE; Lot Numbers: 9276140731046
Catolog No - AK-12703 lot number RF3039028
Catalog Number: 414837 Lot Number: 555011
PCB900 manufactured between 09/13/2010 and 05/22/2012
Best By dates: March 2017 to September 2017

Product Quantity
312 jars (16 oz. each) and 172 jars (32 oz. each)
16,443 cases (containing 3.53 oz plastic jars)

Reason for Recall
This recall is an expansion from the July 3, 6, and 12th 2012. Analysis of two plant retained samples found an elevated level of vitamin D (100X).
The product is being recalled due to contamination with Salmonella.
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.
The product has the potential to be contaminated with Listeria monocytogenes.
Presence of Particulate Matter: The product was discolored and contained visible particulates (iron oxide) in the solution and embedded in the glass vial.
Presence of Foreign Tablets/Capsules:179 doses of Valacyclovir HCl 500 mg tablets were repacked in unit dose packslabeled as Atorvastatin Calcium
Arrow International Inc. is recalling Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe because the component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and potentially product sterility.
Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label.
Blood products, leukoreduced using a Fenwal filter greater than 72 hours of draw, were distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, which were collected from a donor with a history of high risk behaviors, were distributed.
Red Blood Cells, lacking antibody identification labeling, were distributed.
Blood products, which did not meet acceptable product specifications, were distributed.
Shell eggs contaminated with Pseudomonas fluorescens.
Kraft Foods Group is voluntarily recalling 7,691 cases of select varieties of regular Kraft American Singles Pasteurized Prepared Cheese Product. A supplier did not store an ingredient used in this product in accordance with Kraft's temperature standards.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Italian Meatless Pasta Sauce is recalled because review of the production records revealed that one batch of sauce produced had a pH high enough to allow the growth of Clostridium botulinum, a bacterium which can cause life-threatening illness or death.
The default references for normal values are inconsistent between cobas b 221 and other blood gas instruments. In addition, the reference ranges are different when comparing with corresponding ranges listed in the Instructions for Use for the analyzer and the reference literature source.
Failure to produce the Non-Invasive Blood Pressure (NIBP) Measurement.
Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the VITROS 4600 Chemistry Systems and VITROS Integrated Systems. Internal testing confirmed that when using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9, an unexpected assay calibration may occur if assay targets are unassigned (i.e., hidden).
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Firm was notified by supplier that specific lots of ''expo fresh'' Roma tomatoes may be contaminated with Salmonella.
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
Fresh Finds Black Pepper may contain Salmonella.
Product is recalled due to undeclared wheat, milk, and soy.
Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System.
Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use due to reports of inability to remove the stapler from tissue.
Aerogen has received a small number of complaints in relation to the main power adapter manufactured by FRIWO GmbH and used in the Aeroneb Solo and Pro Nebuliser systems. The complaints received identified that the power adapter cover had broken and dislodged from the body of the adapter prior to use.
Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date.
There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple studies may lead to the selection of an incorrect study.
Ameditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphic in the package insert.
An investigation identified that the product was incorrectly manufactured as a left humeral trial but is etched as a right humeral trial.
Firm received several complaints that the head deck actuator bracket had separated from the bed frame.
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, however the pouch label identifies the expiry date of 2016-11.
JAKKS Pacific is recalling Kong Brand Rawhide products because they may be contaminated with mold.
Possible contamination with Listeria monocytogenes.
Presence of Foreign Tablets: Presence of topiramate 100 mg tablets comingled with 200 mg tablets.
Crystallization: Formation of crystals observed in product.
Bumble Bee Foods, LLC, has issued a recall on specific codes of pouched Albacore tuna due to defects in the pouch seals which could result in product contamination by spoilage organisms or pathogens, and could lead to illness if consumed.
Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.