Recalling Firm
Horiba Instruments, Inc dba Horiba Medical
Stryker Medical Division of Stryker Corporation
GE Medical Systems Information Technologies, Inc.
Claudio Wholesale, Inc. (DBA) Claudio Specialty Foods

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

Distribution Pattern
Distributed domestically to AR, CT, FL, GA, IA, IL, LA, MA, MI, MN, NC, NE, NY, OH, TX, VA, WI.
US Nationwide Distributed in the states of AZ, CA, CO, GA, IL, MO, NM, OK, OR, SC, TX
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey
Product was distributed throughout the United States.
Worldwide distribution - United States Nationwide and the countries of Japan, Canada
US nationwide distribution. Also Portugal and the Netherlands.
Distributed to the states of NM, CA, and IL.
Worldwide Distribution - U.S. Nationwide - Latin America
Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey
USA (nationwide) distributed to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY. Distributed internationally to Armenia, Australia, Canada, Chile, Ecuador, El Salvador, Guatemala, Hong Kong, India, Japan, Malaysia, Mexico, Netherlands, Pakistan, Panama, Philippines, Singapore, South Korea, Switzerland, Thailand, United Kingdom, Vietnam.
Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WI & WV.
Worldwide Distribution - US, including the states of : WI, NC, GA, IL, AZ, FL, CA, NJ, and territory of PR; and the country of Canada.
Worldwide distribution in the states of OH, WI, AZ, GA, VA, CA, OK, MN, TN, ME, CO, SC, FL, AL, and Puerto Rico and country of Switzerland
Worldwide Distribution: US (nationwide) and countries of: Algeria, Australia, Austria, Canada, Costa Rica, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Italy, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Norway, Poland, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uganda, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam.
Distributed to distribution centers in AL, IL, IN, and PA
Worldwide Distribution to the countries of : Australia, Canada, Germany, France, Great Britain, Hong Kong, and Ireland
Pennsylvania; Kentucky; Korea, Republic Of(South); Rhode Island; Tennessee
Il, TX, NJ, CA, GA, AZ, HI, CO, OR, UT, WA, NV,
The product was distributed to 5 whole sale Distributors in the following states : NY, IL, NJ, GA, TX
USA (nationwide) Distribution to the states of : AL, CT, FL, KS, LA, MA, MI, MN, MO, MS, NE, NY, OH, OR, PA, TX and WI. Foreign consignees were not reported as device is manufactured outside the U.S.
AZ, CA, CO, CT, HI, ID, IL, LA, MA, ME, MI, MN, OH, OK., PA, RI, SC, TN, UT, VA, WA

Product Description
MAX MAN capsules, 3000 mg, 6-count bottle, labeling is in foreign language
MACA gold tablets, 6800 mg, 10-count bottle, labeling is in foreign language
Tiger King tablets, labeling is in foreign language
DADIYONGSHI XIANGGANGTIANLONGSHENGWU tablets, 6-count bottle, labeling is in foreign language
LANG YI HAO CHAONONGSUOPIAN tablets, 500 mg, 8-count bottle, labeling is in foreign language
YANSHIJIAONANG capsules, 2000mg, 8-count bottle, labeling is in foreign language
Power V8 Viagra tablets, 200mg, 10-Grain bottle, labeling is in foreign language
Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
GOLD VIGRA capsules, 50mg, 6-count bottle, labeling is in foreign language
Indian God Lotion Spray Bottle, labeling is in foreign language
GERMANY NIUBIAN tablets, 3000mg, 10-count bottle, labeling is in foreign language
HU HU SHENG WEI capsules, 3000 mg, 2-count bottle, labeling is in foreign language
Black Ant capsules, 4600mg, 4-count blister pack, labeling is in foreign language
LIEN CHAN FOR SEVEN DAYS capsules, labeling is in foreign language
ZHANSHENG WEIGE CHAOYUE XILISHI tablets, 2000 mg, 6-count bottle, labeling is in foreign language
Miraculous Evil Root capsules, 1200 mg, 6-count bottle, labeling is in foreign language
HARD TEN DAYS capsules, 4500mg, 6-count bottle, labeling is in foreign language
Clalis capsules, 50mg, 6-count bottle, labeling is in foreign language
Ye Lang Shen capsules, 5000 mg, 8-count bottle, labeling is in foreign language
STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language
GERMANY BLACK GOLD tablets, 2800 mg, 8-count bottle, labeling is in foreign language
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug admixtures.
BARD(R) UROS(TM) AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be used in combination with a compatible Edwards hemodynamic monitoring technology module and/or cable and accompanying Edwards accessories and/or disposables. It provides Edwards hemodynamic monitoring technologies through modular connections. The HemoSphere Swan-Ganz Module (HEMSGM10) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that works in conjunction with the HemoSphere Advanced Monitor, patient CCO cable and compatible Swan-Ganz catheter to acquire and process temperature data supporting intermittent cardiac output (iCO), continuous cardiac output (CCO) and right ventricular end diastolic volume (EDV) monitoring. The HemoSphere Oximetry Smart Cable (HEMOXSC100) is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. It is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation by reflectance spectrophotometry. LEDs within the oximetry cable transmit light fiber optically to the distal end of the catheter. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood. This optical intensity data is gathered by the oximetry catheter, processed by the HemoSphere Oximetry Cable, and displayed on a compatible monitoring platform. Parameter output is mixed venous oxygen saturation (SvO2) or central venous oxygen saturation (ScvO2).
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Medline Suture Removal Pack Latex Safe, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Medline General Purpose Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Medline Hip Replacement, Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093
Medline Incision Drainage Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Medline INCISION AND DRAINAGE TRAY Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Medline Skin Staple Remover Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Medline Circumcision Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Medline Staple Remover Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60060
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Medline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093
Medical Equipment Affiliates IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medical Equipment Affiliates., Tahlequah, OK 74464
Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590
Medline Skin Stapler RMVR, Tray Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Medline Central Line Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1
Medline Pacemaker Implant Pack, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
Medline Sheath Removal Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60063
Medline Abdominal Surgery II Pack-LF, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Medline Concordia Nurse Bag Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Medline Laceration Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Medline TRAY, CATHETER CARE, LIDDED. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Medline IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Medline RAD NECK ENT TRAY Pack, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
Medline CNTRL Line Removal Kit Scripps. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Liberator Medical Supply Catheter Insertion Tray, Sterile, Single Use Only. Distributed by: Liberator Medical Supply, INC. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Medline IV Start Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Medline I&D Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Medline Anesthesia Kit, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093
Medline Vaginal Delivery CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Medline Staple Remover Kit, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Medline Vitrectomy CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Medline Catheter Insertion Kit, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Medline DC Line Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Medline Incision Drainage Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
Medline Wound Closure Tray, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Medline Straight Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060
Medline Trunk Kit, Non-sterile. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Medline Incision & Drainage Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Medline Irrigation W/Piston SYR Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Medline Incision and Drainage Tray Kit, Sterile, Single use only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Medline Pediatric IV Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Medline CC Drawer 4 IV Circulation Pack, Contains Rx, Single Use Only, contains 2 Prep Pad PVPs. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Medline NICC Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Medline Debridement Tray, Sterile, Single Use Only. Assembled in USA by Medline Industries, Inc., Mundelein, IL 6060
Medline All Purpose Instrument Tray, Sterile. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Medline General Purpose Instrument Set, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Medline Concordia Trunk Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093
Medline GHS Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Medline General Purpose Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Medline Skin Biopsy Pack-LF, Sterile, Single Use Only. Packaged in USA by Medline Industries, Inc., Northfield, IL 60093
Medline Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 NDC 68462019255 UPC 3684620192559
Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box. Product Usage: The Alere Triage Drugs of Abuse Panel plus Tricyclic Antidepressants uses eight discrete competitive immunoassay procedures for the simultaneous detection and identification of the major drugs and/or the urinary metabolites of eight different drug classes. The use of monoclonal antibodies that are specific for the drugs and/or metabolites of the eight drug classes ensures a high degree of sensitivity and specificity.
Neutrogena deep clean purifying whipped foam cleanser, (Salicylic Acid 0.5%), aerosolized product in a can, NET WT. 5 OZ. (141 g) Distributed By: Johnson & Johnson Consumer Inc. Skillman, NJ 08558. UPC: 0 70501 10053 0
Neutrogena Elevated 4-Holiday Trays (contains Neutrogena Deep Clean Purifying Whipped Foam Cleanser) Case Code: 00070501302866
Neutrogena Acne Proofing whipped foam cleanser, (Salicylic Acid 2%), aerosolized product in a can, NET WT. 5 OZ (141 g) , Distributed by Johnson & Johnson Consumer Inc. Skillman, NJ 08558, UPC 0 70501 11131 4
BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5
SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone
10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 - Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 - Elecsys 2010 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/04775201973 - cobas e 411 analyzer (rack system), medial device listing number: E116019 cobas e 411 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
Affixus Hip Fracture Nail, RH 130 DEG 13MM X 460MM
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 460MM
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 400MM
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 360MM
Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 420MM
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 420MM
Affixus Hip Fracture Nail, RH 130 DEG 13MM X 440MM
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 380MM
Affixus Hip Fracture Nail, 125 DEG 9MM X 180MM
Affixus Hip Fracture Nail, LH 125 DEG 11MM X 440MM
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 360MM
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 260MM
Affixus Hip Fracture Nail, RH 125 DEG 11MM X 300MM
Affixus Hip Fracture Nail, LH 125 DEG 9MM X 260MM
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 280MM
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 300MM
Affixus Hip Fracture Nail, LH 125 DEG 11MM X 320MM
Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 440MM
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 440MM
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM
Affixus Hip Fracture Nail, 130 DEG 11MM X 180MM
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM
Affixus Hip Fracture Nail, RH 125 DEG 11MM X 460MM
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 380MM
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 300MM
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 260MM
Affixus Hip Fracture Nail, RH 125 DEG 11MM X 380MM
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 400MM
Affixus Hip Fracture Nail, RH 130 DEG 13MM X 280MM
Affixus Hip Fracture Nail, LH 125 DEG 9MM X 440MM
Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 420MM
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 400MM
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 420MM
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 280MM
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 260MM
Affixus Hip Fracture Nail, LH 125 DEG 9MM X 340MM
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 340MM
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM
Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 300MM
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 400MM
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 420MM
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM
Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM
Affixus Hip Fracture Nail, RH 130 DEG 13MM X 300MM
Affixus Hip Fracture Nail, LH 130 DEG 13MM X 460MM
Affixus Hip Fracture Nail, RH 125 DEG 13MM X 320MM
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 340MM
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 380MM
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 280MM
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 320MM
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 440MM
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 440MM
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 320MM
Affixus Hip Fracture Nail, RH 125 DEG 13MM X 260MM
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 340MM
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 360MM
Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less.
SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47
bvi Beaver(R) Optimum(TM) Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) Straight 22.5o, REF 378236 (c) Straight 30o, REF 378237 (d) Straight 45o, REF 378238 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
bvi Beaver(R)Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
bvi Beaver(R) Xstar(R) Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) REF 378215, 1.50mm, 45o Bevel Up (c) REF 378217, 1.7mm, 45o Bevel Up (d) REF 378218, 1.8mm, 45o Bevel Up (e) REF 378220, 2.0mm, 45o Bevel Up (f) REF 378222, 2.2mm, 45o Bevel Up (g) REF 378223, 2.3mm, 45o Bevel Up (h) REF 378224, 2.4mm, 45o Bevel Up (i) REF 378227, 2.75mm, 45o Bevel Up (j) REF 378228, 2.8mm, 45o Bevel Up (k) REF 378230, 3.0mm, 45o Bevel Up (l) REF 378232, 3.2mm, 45o Bevel Up (m) REF 378822, 2.2mm, 45o Double Bevel (n) REF 378824, 2.4mm, 45o Double Bevel (o) REF 378825, 2.5mm, 45o Double Bevel (p) REF 378826, 2.65mm, 45o Double Bevel (q) REF 378827, 2.75mm, 45o Double Bevel (r) REF 378828, 2.8mm, 45o Double Bevel (s) REF 378829, 2.85mm, 45o Double Bevel (t) REF 378830, 3.0mm, 45o Double Bevel (u) REF 378832, 3.2mm, 45o Double Bevel (v) REF 370145, 2.5mm, 45o Bevel Up (w) REF 370146, 2.6mm, 45o Bevel Up (x) REF 373025, kojo, 2.5mm, 45o Bevel Up (y) REF 373032, kojo, 3.2mm, 45o Bevel Up Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
bvi Beaver(R) Xstar(R) Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
bvi Beaver(R) EdgeAhead(R) Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
Red Blood Cells, Leukocytes Reduced, Irradiated
Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, to backfill and downpack gutta percha during Endodontic root canal treatment, and when in Extruder mode it is used only to backfill gutta percha during root canal obturation.
Metrotom 800 (130kV CT scanner) Industrial CT scanner for measuring and inspecting complete components made of plastic or light metal.
MA3320-PM Premium Adult - SYK Mistral-Air Premium Blankets. MODEL #: MA3302-PM. CATALOG #(s): MA3302-PM
Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16
GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 The CARESCAPE Central Station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors and telemetry systems can be displayed, provide alarm annunciation, and can be printed from the CARESCAPE Central Station.
Coat & Bake, Original Chicken, Seasoned Coating Mix For Chicken, Net Wt 5.5 OZ (156 g), Distributed by SuperValu Inc., Eden Prairie, MN.
Mary B's Made with Whole Grain, 220CT, Bulk Biscuits
Mary B's Jumbo, 10 Biscuits, Extra Large, NET WT. 35 oz (2LB 3OZ) 992g
Mary B's Thins , 22 Biscuits, NET WT. 28.3 oz (1LB 12.3 OZ) 810g
Mary B's Butter Taste, 20 Biscuits, Value Pack, NET WT. 44 oz (2LB 12 OZ)1247g; and Mary B's Butter Taste, 30 Biscuits, Family Pack, NET WT. 60 oz (3LB 12 OZ) 1701g
Mary B's Buttermilk 0 Trans Fat 220 CT, Bulk Biscuits
Mary B's Buttermilk, 12 Biscuits, NET WT. 26.4 oz (1LB 10.4OZ) 748g; Mary B's Buttermilk, 20 Biscuits, Value Pack, NET WT. 44 oz (2LB 12 OZ) 1247g; Mary B's Buttermilk, 30 Biscuits, Family Pack, NET WT. 60 oz (3LB 12 OZ) 1701g; Mary B's Buttermilk Biscuits, 220CT, Bulk Biscuits; and Mary B's 3.5 oz Jumbo Buttermilk, 144CT, Bulk Biscuits
Mary B's Southern Made, 12 Biscuits, NET WT. 26.4 oz (1LB 10.4OZ) 748g; Mary B's Southern Made, 20 Biscuits, Value Pack, NET WT. 44 oz (2LB 12 OZ) 1247g; and Mary B's Southern Made, 30 Biscuits, Family Pack, NET WT. 60 oz (3LB 12 OZ) 1701g
Mary B's Tea Biscuits, 24 Biscuits, Bite-Sized, NET WT. 24 oz (1LB 8 OZ) 680g
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.
Sapori di Mare Colatura di Alici di Cetura; Anchovy Sauce; 100 ml, Lot #'s 03/2017 or 09/2017.
Graseby 3300 Pump and Graseby 3000 Series Pump Accessories Patient controlled syringe pump. Use for Infusion
Cheesecake Bars, PLU number 240801, 2 oz. UPC: 0240801001992
Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office Use Only, Not for Resale. Fagron Sterile Services/JCB Laboratories, 7335 W. 33rd St. N., Wichita, KS 67205
Jarrow Formulas Liquid L-Carnitine; 16 fl oz. (475 ml) bottle, dietary supplement; product number 102006; UPC 7 90011 02006 6; Vitamin B5 10 mg; L-Carnitine 1000 mg; Other ingredients: Purified water, xylitol, glycerin, citric acid, natural lemon-lime flavor, nisin (as a preservative). Distributed exclusively by Jarrow Formulas Los Angeles, CA.
Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated
Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis Platelets, Leukocytes Reduced, Irradiated
Ottogi Rice Cake Soup, 6.4oz. UPC 6 45175 89093 52; Item Number 29409101; Ingredients: 1. Rice Cake: Rice Water, Salt, Spirits; 2. Liquid Soup: Beef Bone Extract, Prim/starch syrup, coconut oil, sodium Caseinate, Water, Salt, Maltodextrin, Garlic, Chicken Extract Powder. (USA) Sugar, Black Pepper, monosodium glutamate,5ribonucleotide 3. Dehydrated vegetable mix: Green onion, soybean protein, seaweed. Product of Korea. Manufactured by Ottogi Frozen Foods Co., Ltd., Gyeonggido, Korea. Distributed by Ottogi America Inc.
Wegmans Ready To Cook Garlic Parmesan Tilapia, Single, 5 oz UPC: 2-16150-00000 and Wegmans Ready To Cook Garlic Parmesan Tilapia, Twin Pack, 15 oz UPC: 2-16154-00000
Wegmans Ready To Cook Shrimp Scampi, 6 oz. UPC: 2-16151-00000
Wegmans Ready To Cook Lobster & Shrimp Steam Pot, Sold by the lb. UPC: 2-16326-00000
Wegmans Ready To Cook Tom Tom Shrimp with Sauce, 11 oz UPC: 2-06048-00000
Sun Noodle brand Tonkotsu Ramen, Packaged in plastic clear clamshell, Banded with Tonkotsu label, distinguishable with a yellow color. (12/case); UPC 0 85315 40003 5
Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY --- NDC 31722-917-01
Blood and Blood Products for Reprocessing
PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50 tablets NDC 55289-673-50; d) 60 tablets NDC 55289-673-60
Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3
Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 Syngo.plaza is a Picture Archiving and Communication System (PACS) software device intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.
IASA COLATURA DI ALICI DI CETARA ANCHOVY EXTRACT; 100 ml and 250 ml sizes; UPC 100 ml - 7 93232 54200 3; UPC 250 ml - 7 93232 54203 4 Ingredients: Anchovies, Salt, Water. Product of Italy. Produced by ISA srl Pellezzano (SA)
Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05
Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05

Product Quantity
240 case, 12 cartons per case = 2,880 cartons
216 cs, 12 units/case Imported from IASA SRL, Pellezzano, Italy
811 CS FOR 100ML AND 101 CS FOR 250ML (6 units per case)

Reason for Recall
Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Marked Without An Approved NDA/ANDA: FDA analysis found this product to contain diethyl phthalate, an inactive ingredient in several modified release solid oral dosage forms, making this product unapproved drug for which safety and efficacy have not been establish and therefore, subject to recall.
A leak may allow for microbial contamination of the sterile fluid path.
Products may not meet specifications due to possible presence of metal shavings.
The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies resulting in an impact on clinical treatment decisions.
Pre-procedural issues related to software defects
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
The recalled lots have demonstrated unexpected false positive THC results.
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)
The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm.
One lot of fresh cut Jicama Julienne contaminated with Listeria monocytogenes.
A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
55 kits were distributed after their expiration date of September 2015.
This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential malfunction has been attributed to aging and premature deterioration of the Pl collector current.
The firm received 200 reports in which the protective shield was retracted.
Blood products collected from a donor for whom donor suitability was not adequately determined, were distributed.
Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
The firm received Ice Oatmeal Cookies that actually contain Coconut Macaroon Cookies. Product is being recalled due to mislabeling. Product contains both milk and tree nuts that are not listed in the ingredient statement.
Due to a software error, it was observed that when the user closes the access door, the system will resume its scan cycle automatically, instead of the user initiating x-ray generation from the control panel.
It was identified that the Mistral-Air Premium blankets may be capable of conducting electricity during a defibrillation or cardioversion therapy at higher energy levels (70 Joules or more) when the blanket is applied with the reflective side toward the patient (upside down).
LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg.
CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after boot-up or system restart.
Kvas, a fermented non-alcoholic drink, due to bulging. A hole was punched to the lids of the gallon plastic jugs to prevent the plastic jugs from bulging. The package integrity was compromised.
not declared on the Coat & Bake Chicken product
Products have the potential to be contaminated with Listeria monocytogenes.
Labeling: Label Error on Declared Strength
Claudio Specialty Foods is recalling anchovy sauce after receiving a telephone call from their supplier notifying them that the product was found to contain high levels of histamine.
In certain cases, the lock and key supplied with Graseby 3300 pumps and accessories does not match the standard Graseby 3300 key.
Product may contain undeclared almond flour.
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
A higher than normal micro result was found at the six month time point for one lot of Liquid L-Carnitine.
Blood products, collected from ineligible donors, were distributed.
Firm determined that their Rice Cake Soup has undeclared milk in the form of sodium caseinate.
Products may contain undeclared soy lecithin.
Product is labeled as Tonkotsu, but the actual flavor packet inside is Assari Shoyu , which contains a fish (sardines).
Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Blood products, collected from donors who lived in malarial endemic areas, were distributed.
Software update to correct several issues that include (1)Potential data loss, (2) Study mix-up, (3) Incorrect measurements on multi-frame images, (4) Dearchiving issue, and (5) Unauthorized access of data due to inadequate permissions for shared folders.
Rapid Alert System for Food and Feed notification received from Italy regarding high histamine levels in imported anchovy sauce.
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability

Code Info
Product Code 2J8003, Lot No. DR16J18096.
Pack Number: DYNJ48244B; Lots 17FB2504; 17HB2544
Pack Number: P888943; Lots 17RB8662 Pack Number: P888937H; Lots 17QB8268
Pack Number: DYNDD1039; Lots: 17GB4725; 17HB4905
Pack Number: DYNDR1184; Lots: 175B2484; 17HB1903
Pack Number: DYNDR1067; Lots: 17PB4605 Pack Number: DYNDR1067H; Lots: 17PB4605
Pack Number:DYNDR1165; Lots: 15HB6327; 15HB4355
Pack Number: P888899; Lots 17RB8659; 17GB5162 Pack Number: P888899H; Lots 17RB8659
Pack Number: P888937; Lots 177B0658; 17QB8268 Pack Number: P888937H; Lots 17QB8268
Pack Number: DYNDR1018A; Lots: 17RB8658; 17HB1913
Pack Number: DYKSCRIPPSCL1; Lots: 17HA1756
Pack Number: DYNDT1022E; Lots 17QB4402; 17TB1979
Pack Number: DYNJAA6606; Lots 178B1823; 17HB2055
Pack Number: DYNDR1111; Lots: 17FB1191; 17HB1905 Pack Number: DYNDR1112A; Lots 177B0660; 175B2485
Pack Number: DYNDR1118; Lots: 17SB4219; 175B2486
Pack Number: DYNDC1971; Lots: 175B1999; Pack Number: DYNDC1971H; Lots: 17OB8570; 175B1999
Pack Number: P888943; Lots 17RB8662 Pack Number: P888943H; Lots 17RB8662
Pack Number: DYNDA1465; Lots: 17HB4903; 17CB8548
Pack Number: DYNDR1109; Lots: 17NB0789; 17EB4269 Pack Number: DYNDR1109H; Lots 17EB4269
Pack Number: DYNDR1186; Lots: 17EB0360; 177B1719 Pack Number: DYNDR1186H; Lots: 16PB7974; 17EB0360
Pack Number: DYNDR1157; Lots: 177B0661 Pack Number: DYNDR1157H; Lots: 177B0661; 17QB1693
Pack Number: DYNDR1161; Lots: 17RB9449 Pack Number: DYNDR1161H; Lots: 17RB9449
Pack Number: DYNDL1488; Lots: 177B0657; 17QB3332
Pack Number: DYNDS1014; Lots 17GB3416; 176B2045
Pack Number: DYNDA1591; Lots: 17GB5136; 17PB2138
Pack Number: DYNDC2282; Lots: 16CB5897; 16PB9981
All Photo Interrupter sensors that are current in AIA-900 analyzers with serial number(S/N) 10000103 to S/N 11147003.
(a) REF 378235; Batch Numbers: (b) REF 378236; Batch Numbers: (c) REF 378237; Batch Numbers: (d) REF 378238; Batch Numbers:
Part Number for Elements Obturation Unit (EOU): 973-0322; and Part Numbers for the Buchanan Heat Pluggers: 952-0004, 952-0003, 952-0005, 952-0006, 952-0007, 952-0031, 973-0219 (hot pulp test tip). All serial numbers of the EOU and respective Buchanan Heat Pluggers are included in the recall.
Lot Number: JLC17131; Expiration date: 05/2019
Only packages with use or freeze by dates from January 11th to January 23rd are affected.
Syngo.plaza with software version VB20A; Model numbers: 10863171, 10863172, 10863173