Blood product, collected from a donor whose arm check and general appearance inspection were not documented, was distributed.
Blood Bank of San Bernardino and Riverside Counties
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood and Blood Products for Reprocessing
Blood products, which should have been quarantined pending an investigation, were distributed.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Blood product, possibly contaminated with P.acne, was distributed.
Blood products, collected from a donor during a deferral period for travel to a malarial endemic area, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected from a donor taking the drug Avodart, were distributed.
Blood and blood products for reprocessing
Blood products, collected from a donor who was previously deferred, were distributed.
Blood products which tested negative for all viral markers, were collected from a donor who subsequently tested positive for hepatitis C (HCV) by NAT.
Blood products, for which the West Nile Viral testing performed was incomplete, were distributed.
Blood products, for which West Nile Viral testing was incomplete, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, collected from a donor for whom hemoglobin screening test was not performed, were distributed.
Multiple states within the U.S.  Firm could not provide specifics.
Blood products, possibly contaminated with air during collection, were distributed.
Blood products, collected from donors who reported travel to malarial endemic areas, were distributed.
Platelets Pheresis Leukocytes Reduced Irradiated
Worldwide Distribution - USA including CO, PA, TN, VA, TN, WA, and internationally to Czech Republic.
Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847   The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The Oracle Spacer is indicated as a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures or the treatment of tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Slap Hammer, 03.809.690, is a dual sided device with two separate attachment options. The Slap Hammer allows a user (surgeon) to remove a previously placed trial implants.
Part number 03.809.690, Lot Number 6723847
This recall is being initiated in response to complaints received where it was reported that the proximal end of the Slap Hammer broke during use.
Nationwide Distribution including CA,and VA.   .
Synthes 3.5 MM LCP(R) Distal Humerus System   The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults and adolescents (12-21) in which the growth plates have fused. Specifically, distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.
Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).
Worldwide Distribution - USA including 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.  Internationally to Canada, Australia, Bermuda, Brazil, China, Costa Rica, Germany, France, United Kingdom, Guam, Hong Kong, Israel, India, Kuwait, New Zealand, Puerto rico, Qatar, Saudi Arabia, Singapore, Thailand, Trinidad, Tobago, and South Africa.
Invacare Power Wheelchair, one per box   To provide mobility to a person restricted to a sitting position.
The following Joystick model numbers and respective part numbers are affected by this recall:  CSPJ, 1121239; SPJPLUS, 1127291; SPJAP, 1136937; SPJAPM, 1136938; CMPJM6, 1164361; CMPM6U, 1644361; MPJM6, 1136885; MPJM6U, 1136885; 1558M6, 1136887; 1558MM6, 1136887; 1500M6, 1136889; PACM6, 1136888; PACM6, 1167927; PSRM6, 1139941; PSRM6, 1140046; PSRM6, 1140047; PSRM6, 1140048; PSRM6, 1144844; PSRM6, 1144845; and PSFM6, 1139944.     The following Power Wheelchair model numbers (affected date ranges are included in the 1525712 6-3-13 001C model numbers FINAL xlsx document) are affected by this recall:  M61UKRD; 3GAR; 3GARBASE; 3GAR-CG; 3GRX; 3GRXBASE; 3GRX-CG; 3GSEAT-CG; 3GSTRX-TS; 3GTQ3; 3GTQ3-CG; 3GTQ3-MCG; 3GTQ3V; 3GTQ-CG; 3GTQ-MCG; 3GTQSE; 3GTQSEBASE; 3GTQSE-CG; 3GTQSE-PTO; 3GTQSP; 3GTQSPBASE; 3GTQSP-TS; FDX; FDX-CG; FDX-MCG; M41BB; M41RB; M41RBCN; M51 PBLUEBASE; M51 PREDBASE; M51BB; M51-CG; M51CGBB; M51CGRB; M51P; M51PBB; M51PBLUEBASE; M51PR; M51PRB; M51PREDBASE; M51RB; M51RBCN; M51SEAT-CG; M61; M61 PBLUE; M61 PRED ; M61 ; KRDBASE; M61(1144227); M61FBLUE; M61FRAD; M61FRED; M61R; M61RB(1144227); M61RBCN; M61RED; M61SEAT; M61UK; M61UK REDBASE; M61UKRD; M61UKRDBASE; M71; M71JR; M71R; M71SEAT; M71-TS; M91; M91-C; M91-M; M91R; M91-R; M91SEAT; M91-TS; M94; M94-C; PTBASE; PTORB; PWORBITS; R51; R51LXP; TDX3; TDX3BASE; TDX3-PS; TDX3SE; TDX3SEBASE; TDX3SE-PS; TDX3SE-TS; TDX3-TS; TDX4; TDX4BASE; TDX4-PS; TDX4-TS; TDX5; TDX5BASE; TDX5-PS; TDX5-TS; TDXSC; TDXSC2-CG; TDXSCSEAT; TDXSCV; TDXSEAT; TDXSI; TDXSI-2; TDXSI-2-S; TDXSI-CG; TDXSI-HD; TDXSI-HD-S; TDXSISEAT; TDXSISEAT-HD; TDXSIV; TDXSIV-2; TDXSIV-2-S; TDXSIV-HD; TDXSIV-HD-S; TDXSP; TDXSPBASE; TDXSP-CG; TDXSP-CG-GT; TDXSP-GT; TDXSP-MCG; TDXSP-MCG-GT; TDXSPREE; TDXSPREE-CG; TDXSPREESEAT; TDXSPSEAT; TDXSR; TDXSR-CG; TDXSR-CG-HD; TDXSR-HD; TDXSR-MCG; TDXSR-MCG-HD; TDXSRSEAT; TDXSRV; and TDXSRV-HD.
Unintended slowing or deceleration, and on rare occasion, unanticipated and unattended acceleration of power wheelchairs equipped with SPJ and MPJ type joysticks.
Blood Systems, Inc. dba United Blood Services Texas
Blood products, collected from a donor who traveled to a malaria endemic area, were distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood product,  labeled with an incorrect expiration date and product code, was distributed.
Blood Centers of the Pacific - Irwin Center
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
American Red Cross Blood Services Heart of America Region
US Distribution including the states of  DC, MA, NJ, TX. FL, CA, WA, NY, TX, CT, KY, LA, AR, TN, AL, GA, CT, VA, NC, KS, MD, OH and IL
DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD    Mfg by:  Microgenics Corporation,  46360 Fremont Blvd.  Fremont, CA 94538    The DRI Cocaine Metabolite Enzyme Immunoassay is a homogeneous enzyme intended for the qualitative and semi-quantitative determination of benzoylecgonine (Cocaine Metabolite) in human urine with either 300 ng/mL or 150 ng/mL as a cutoff calibrator. The assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirm analytical result.
Surveillance of reagent stability for specific lots of  DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate, indicating a faster than expected reagent degradation.
Pyridostigmine Bromide Tablets, USP Rx Only 100 Tablets, Manufactured and Distributed by: CorePharma, LLC Middlesex, NJ 08846 NDC 64720-128-10 NDC 64720-128-10
Failed Stability Specifications: Pyridostigmine Bromide tablets, is being recalled due to an out of specification test result during stablity testing.
Stryker Medical Division of Stryker Corporation
Worldwide Distribution - USA including MI, WI, VA and internationally to Canada.
The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in electric DC motors and remote controls that is intended for medical purposes. It can be operated by the patient or the caregiver to adjust the height and surface contour of the bed. The bed includes movable and latchable siderails.  The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms.   The FL23SE Bed is intended for use with patients for procedures, therapy, recovery in healthcare environments, and to transport patients between bays and procedural rooms.
The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the opening of the bed head box. If an accessory (i.e. IV pole) is inserted into this slot, the circuit directing the nurse call system can be damaged.
Nationwide Distribution including WA, IN, OK, TX, MI, CA, NY, CT, AZ, FL, WV, NC, VA, PA, TN, GA, AL, MA, SC, OH, MS, MO, SD, WI, AR, AND NV.
Terumo Pall AL6X Arterial Blood Line Filter, labeled in part ***Terumo Cardiovascular Systems Corporation Elkton, MD 21921***, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit   Single/Sterile Terumo Pall AL6X Arterial Filter: The Terumo Pall AL6X Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of micro-emboli greater than 40 microns in size, including gas emboli, fat emboli and aggregates composed of platelets, red blood cells and other debris from the arterial line and where the flow rate will not exceed 8 liters per minute. Cardiovascular Procedure (Convenience) Kit that includes the Terumo Pall AL6X Arterial Filter: The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed. The sterile cardiovascular procedure kit is intended to be used one time for periods up to 6 hours.
Recalled filters sold singly are identified with Part Number AL6X with the following lot codes: MM19, MN23, NC15, ND01, ND08, ND29, NE11, NE18, NE25, NF09, NF31, PA23, PD05, PE02, PF14, PF21, PG04, PG11, PG18, PG25, PH09, PH16, PH30, PK06, PK13, PL24, PM01, PM08, PM22, PM29, PN12, PN26, PP17, PP31, QA07, QA14, QA21, QC04, QC25, QD11, QD18, QD25, QE08, QE15, QE22, QE29, QF06, QF28, MM26, NL12, NM24, NP12, and PA30; Affected filters, also Part # AL6X, packaged within Terumo Cardiovascular Convenience Kits are identified with the following lot codes: PN19, QA14, QC11R, QD04, QE15, QF06, QF13, NM31, NP05, PC20, PD05, QF28, QC04, PD26, PG04, PE23R, PK13, PK20, QA21, QC11, QC11A, QD11, QE01, PL17, QE08, NK08, PG25, PN26, QC18, NN07, NN07R, PA16, PA16R, PC27, PC27R, PF07, PL24, PD12, PE09, PE30, PH09, PL10, PE23, PF14, PG18, PK06, PM01, PM22, PN12, QA02, QA28, QC25, QD25, NK01, NK08R, PH23, PH16, PL10A, PM15, PP10, PP17, QD18, QE22, NM17, NM17A, PC06, PC06R, PE09R, QE01A, QE15A, QE15T, QE15TA, QE15TC, QF13T, QF20, QF20T, NA10R, NA17R, ND14, ND28, ND28T, NE11T, NE18, NF23, NG06, NG20, NH11, NH18, NK15, NL12, NL26, NM03, NM10, NM24, NN14, NN28, NP12, PA30, PC13, PD19, PE16, PF07A, PF21, PK27, PK27A, PL04, PM08, PP03, QA14T, QE29, QF28T, QF28TA, PG11, PH30, PH30A, PN26A, QA07, NH25, NK29, PE02, PF29, PN19, QG17, PK13A, QD11A, MN22, NE25, NF31, PM29, PA09, QG03, PA02, PH23T, PG11T, QC18R, QF06A, PH09T, PH09TA, QF13TA, QF20TA, and QF20TC
Medical device used in cardiovascular procedures is defective.
Worldwide Distribution - All states in continental USA including DC except AK, AZ, RI  and WY.  and the countries of : AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEANON, MARINIQUE, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE,SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, LUXEMBOURG, PORTUGAL, VIETNAM and URUGUAY.
GE 1.5T Signa HDxt, 3.0T Signa HDxt, Signa Vibrant, HD23 Software and the following model numbers: 2395001, 2395001-2, 2395001-3, 2395001-4,  5269997-2, 5269997-4, 2377062-61, 5127452-3, 5127452, 5337894-3, 5337894-4, 5911000-4, 5911000-5, 53085735308573-2.   GE Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T.    The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. IT is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used
GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products.   For ClariView and Screen Save from GVTK (Gems Visualization ToolKit) Viewer, the MR Product can generate image headers with non-unique series identifiers, which when exported to some PACS systems, results in the series being associated with the  incorrect study on the PACS. The intended study will not have the correct series listed and an unintended study will have it listed instead. In all cases, patient identifying annotation remains correct. The issue may result in an incorrect diagnosis from the  study with mixed patient data, if the series protocol and anatomy on the studies are similar, and the annotation is not noticed.
Nationwide Distribution including AK, CA, CO, CT, FL, IL, IN, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, WA and Puerto Rico.
Monaco RTP System   Radiation treatment planning
Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.
Distributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and  WA.
Monaco RTP System Radiation Therapy Treatment Planning System.    Radiation treatment planning.
Patient needs to be positioned as indicated by the treatment plan.
Worldwide Distribution, including Nationwide (US) and foreign countries.
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
QUADROX-iD Adult catalog number HMOD 70000, lot # 70081567 QUADROX-i Adult  catalog number VKMO 70000, lot # 70082663  QUADROX-i Adult catalog number VKMO 71000, lot # 70083974
The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.
Worldwide Distribution - USA including NY and PA and internationally to Australia, Brazil, Canada, Germany, Hong Kong, Japan, Sweden.
TEGRIS system    Four labels of the Tegris System include:    Emergency button (1703.72)    MAQUET GmbH & Co. KG  Kehler-Strabe 31  Baden-Wuerttemberg  76437 Rastatt, Germany     Touch screen (elo)    Elo TouchSystems 301 Constitution Drive  Menlo Park, CA 94025  www.elotouch.com  Manufacturer: Tyco Electronics  Brand Name: Elo Touch Systems  Made in China    Tegris system (1703.01)    MAQUET GmbH & Co. KG  Kehler Strabe 31  76437 Rastatt, Germany     OR Table Module (1703.71)    MAQUET GmbH & Co. KG  Kehler Strabe 31  Baden-Wuerttemberg  76437 Rastatt, Germany    Designed to be used as the central operating system in an operating room. The integration system has two main functions. -recording and distribution of images and videos -interaction with medical and non-medical devices. The system has a modular design and comprises the basic units as well as s various optional modules,which may be used or integrated in conjunction with the basic unit. TEGRIS is operated using a touchscreen. Medical devices that can be operated by TEGRIS include OR tables an OR lights. In the case of OR tables and OR lights, the main functions of these devices may be separated, e.g. adjustment of OR tables or switching the OR lights on.off. TEGRIS has no effected on the primary operating functions of the original control device. TEGRIS does not provide any other functions in addition to these primary operating functions. The purpose of TEGRIS namely the central operation of these various devices, is dependant on the individual devices. Please refer to the operating instructions of the individual devices for instructions. The integrated surgical safety checklist is a raft and must be modified to meet local requirements and approved by the User. TEGRIS is intended for short-term use pursuant to Appendix IX of the Directive 93/42/EEC of medical products in medical rooms in accordance with Group 1 and 2 VDR 0100-710, providing, among other things, protection against electric shock and connections for potential equalization lines. Intende
Class 1 exempt Device Listing #D122038    Tegris Base System 1703.01X0  OR TAblet Module 1703.71A0    Secondary 19'' touchscreen - part number 1707.05A0    The above product is affected only when used in combination with     Tegris base system 1703.01X0  OR Table Control 1703.71A0
MAQUET has identified a potential issue that might occur because of the lack of an emergency stop button on a secondary touch screen display on the TEGRIS System.
Distributed in the states of FL, TX, and VA.
ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description   5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA.   Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.
Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.
ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description   5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA.   Intended for grasping, dissecting, retraction, clamping in conjunction with the laparoscopic during laparoscopic surgery.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution - USA including FL, VA, TX, NY, IL, AZ, MI, RI, NJ, SC, MO, TN, CA, MN, UT, GA, NE, OH, MD, PA, MT and internationally to Brazil, Australia, Canada, and Puerto Rico..
BD Epilor Syringe BD Franklin Lakes, NJ 07417    BD EDC Laagstraat 57, B-9140 Temse-Belgium    The Epilor syringe is used in conjunction with an epidural needle with the purpose of finding the epidural space.
BD has received several reports indicating that the plunger of the 7 mL BD Epilor plastic BD Luer-Lok Loss of Resistance Syringe may stall or stick within the syringe preventing the user from detecting a loss of resistance upon entering the epidural space.
Breaded, frozen shrimp packaged in plastic bags labeled in part: BREADED SHRIMP; NET WEIGHT; 2.0 LBS or 3 LBS
Packages of breaded shrimp failed to declare shellfish (shrimp) and wheat allergens.
Blythedale Farm Vermont Brie,   7 oz. wrapped disc in plastic cup  UPC Code: 762713669010
Best Buy or Sell By date prior to October 19
Blythedale Farm Farmstead Brie,  1 lb white wrapped disc   UPC Code:
Blythedale Farm Camembert Vermont, 7 oz  wrapped disc in plastic cup UPC Code: 762713669027
SmartSite Low Sorbing Infusion Set, Model#72313E   The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite Low Sorbing set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a 1.2 micron filter, needleless SmartSite connector, low sorbing tubing segment, pinch clamps, and luer connectors.
CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on this lot.  The correct filter is a 1.2 micron  filter (blue color) but a 0.2 micron filter (clear color) may have been added instead.
Class II Recall -  United States   ***Center Recommended Depth - Consumers/Users**
SmartSite Low Sorbing Infusion Set, Model# 10015048.  Intravascular administration set.
CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.
CareFusion Gravity Set, Model #44000-07   The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a check valve, injection ports, 4-way stopcock, anti-siphon valve, roller clamp and tubing.
CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date.  The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years.
retail Spartan stores located in MI and Toledo, OH.   Expanded recall: WI, MN, IA, IL, OH, IN, TX, FL, MA,MO, MI, PA, AZ, CA.
spartan fresh selections american potato salad, Net Wt. 16 oz (1 LB) 454g.  UPC 11213-90320.
One lot of Spartan Fresh Selections American Potato Salad has the potential to be contaminated with Listeria monocytogenes.
Pecan Brittle's label is read in parts: ''***PECAN BRITTLE***INGREDIENTS: Sugar, corn syrup, pecans, brown sugar, butter (cream, salt), baking soda, salt. NO PRESERVATIVES ADDED***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free 1-888-636-CANDY***''.
Finished product labels declared butter or cream but milk is not listed.
Almond Brittle's label is read in parts:''***ALMOND BRITTLE***INGREDIENTS: Sugar, corn syrup, almonds, brown sugar, butter (cream, salt), baking soda, salt. NO PRESERVATIVES ADDED***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free 1-888-636-CANDY***''.
Coconut Peanut Brittle's label is read in parts:''***COCONUT PEANUT BRITTLE***INGREDIENTS: Coconut (preserved with sodium metabisulfate), peanuts, white sugar, glucose, water, butter (cream, salt), vanilla, salt***Net Wt. 8 oz.***www.snofallscandy.com***Toll Free 1-888-636-CANDY***''.
Coconut  Brittle's is labeled in parts: ''***COCONUT BRITTLE***INGREDIENTS: Coconut (preserved with metabisulfate), white sugar, glucose, butter (cream, salt), vanilla, salt***''.
Product was distributed to 6 hospitals in Honolulu and California.
Human breast milk, pasteurized, 4 oz, in bottles; Pasteurized Human Milk,Hospital Grade Milk.    Mother's Milk Bank  751 S. Bascom Abe.San Jose, CA 95128
Human Breast milk was collected from a donor that tested reactive for Hepatitis B in a screening test.
Horiba Instruments, Inc dba Horiba Medical
Worldwide Distribution - USA including the country of Canada.
ABX PENTRA Calcium CP Reagent, Model # A11A01633   Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calcium intake and calcium absorption and excretion. Urinary excretion is an important determinant of calcium retention in the body. Decreased total calcium levels can be associated with diseases of the bone apparatus (especially osteoporosis), kidney diseases (especially under dialysis), defective intestinal absorption and hypoparathyroidism. Increased total calcium can be measured in hyperparathyroidism, malignant diseases with metastases and sarcoidosis. Calcium measurements also help in monitoring of calcium supplementation mainly in the prevention of osteoporosis.
HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent.
Worldwide Distribution - USA including  AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and  internationally to Australia, Canada, Chile, China, Argentina, Guam, Taiwan, India, Japan, Korea, Latin America, Philippines, Mexico, New Zealand, Hong Kong, Singapore, and Switzerland.
Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients.  Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose   The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker Vision Mounting Arm can be used with any Stryker flat panel display and is It is compatible with Stryker Carts (0240099001, 0240099011 or 0240099020). It is indicated for use in a surgical operating room environment and is exposed to environmental conditions associated with the storage and shipping of the product. It is not intended to enter the sterile field. The Stryker Vision Mount does not deliver to and/or extract from the patient any energy or material. It does not process any biological materials, as it is not intended to be sterilized by the user. The Stryker Vision Mount is only used to display surgical images and video and does not sustain or support life.
Model number 0240-095-200, all serial numbers.
When positioning the display located on top of the video cart, it is possible for the user to apply excessive force and push the display up and out of the mounting arm. This can result in the display falling upon the user/patient.
KDK Management, Inc., dba Bubbles Baking Co.
First Street Blueberry Muffins (S 45395), 14 oz., 9 trays/case, UPC 0 4151210833 4
Bubbles Baking Co. is recalling Blueberry muffins and Loaf cakes because they may contain undeclared milk and soy.
First Street Blueberry Muffins Loaf (S 45383), 16 oz., 12 trays/case, UPC 0 41512 10854 9.
Worldwide Distribution - USA including AZ, AR, CA, GA, IL, IN, KY, MD, MA, MI, NV, NJ, NY, NC, OH, OR, PA, RI, SC, TN, TX, VA, WA, WV, WY. Internationally to DENMARK, BELGIUM CANADA.
Smith Medical, Deltec,  REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only   PORT-A-CATH and PORT-A-CATH II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.
Smiths Medical is conducting a voluntary recall of PORT-A-CATH and PORT-A-CATH II Implantable Venous and Arterial Access Systems and Introducer Sets.    Smiths Medical has become aware of a small number of customer reports regarding the introducer sheath and the introducer opening being too small for the width of the catheter with the use of these Sets.    Smiths Medical has received no reports of serious injury or death related to this issue.
Smiths Medical, Deltec:   REF 21-8011-24 Port-A-Cath Dual-Lumen. Titanium Venous Access System.  REF 21-8052-24 & REF 21-8053-24 , Port-A-Cath II Dual-Lumen, Polysulfone /Titanium Venous Access System.    Sterile EO, Rx Only.    PORT-A-CATH and PORT-A-CATH II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions and for the sampling of venous blood. Introducer sets are indicated for the introduction of catheters into the subclavian vein.
Worldwide Distribution-USA (nationwide) including the states of AK, CO, FL, GA, HI, ID, IL, KS, LA, MD, MN, MO, MT, NE, NM, OH, PA, SC, UT, & WY and the countries of Australia, Canada & Spain.
Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com.   The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical devices.
The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed FUJINON G5 & G8 type flexible GI endoscopes does not connect to the main air/water channel within the light guide (LG) connection head and, as a result, the air pipe does not receive forced flow during the Reliance EPS processing cycle.
JAMES FARM brand CUT GREEN BEANS (EJOTES CORTADOS), FRESH FROZEN, NET WT. 32 OZ. (2 LBS.) 907 g, UPC 7 60695 01004 2, PRODUCT OF POLAND -- Distributed by RD/JET, LLC 15-24 132nd Street, College Point, NY 11356 --- Product is harvested, sorted, graded, washed, cut/processed and blanched before snap freezing and packing. The cut green beans are instantly quick frozen (IQF) and packaged in a pre-printed sealed plastic bag, 2 lbs. of product per bag, 12 - 2 lbs. bags per master carton.
The product was found to be contaminated with Listeria monocytogenes based on private laboratory testing.
Meijer 8 Inch Carrot Uniced Split Cake Layers (product is packed in bulk cartons of 24 units/paper bags lined with flexible blue plastic liner).
1561 cases with 24 cakes/case (37464 individual cakes)
Product was found to contain foreign material, flexible plastic.
Product was distributed to PA, VA and MD.
Fresh Herbs Everyday Basil, Shenandoah Growers brand, packaged in .75 oz; 2 oz.; and 2.5 oz. in 3 count and 6 count cardboard sleeves and labeled in part ***Shenandoah Growers Inc., Harrisonburg, Va 22802***
Fresh basil may be adulterated with pesticides.
Basil, fresh, Giant brand, packaged in 2.5 oz. package and labeled in part ***Distributed by FoodHold USA Landover, MD 20785***
Local and nationwide wholesale distributors and retail markets.
Irene's Black & White Cookies, 8 oz. (226.4g)    All Natural.    Ingredients: Sugar, wheat flour, water, eggs, canola oil, unmodified food starch, corn syrup, vegetable fat, cocoa powder processed with alkali, mono and diglycerides, sea salt, sodium acid pyrophosphate, sodium bicarbonate, mono calcium phosphate, soy lecithin, natural flavors.     May contain traces of tree nuts.     Manufactured by Irene's Bakery and Gourmet Kitchen, Bensalem, PA.
actual date code information are not available. Two-week expiration dates are assigned by the retail store upon receipt of shipment from the manufacturer.
2008 packages (87 cases of  24 or 16 eight oz. packages/case)
Undeclared whey powder (milk allergen) sub-ingredient of chocolate confectionery coating used in manufacturing of Black & White Cookies.
Arizona, California, Colorado, Nevada, Utah, Washington, and Wyoming.  324 cases were distributed to govt/military/VA consignees.  No foreign consignees.
Dannon ACTIVIA LIGHT Nonfat Yogurt Strawberry-Banana & Peach Flavor, 12 PACK of 4oz cups, Form fill seal 4oz cup
UPC 36632 02764 With the following expiration codes: Expiration code of PLT 49-64 SEP 24 2013 WJ, Expiration code of PLT 49-64 SEP 29 2013 WJ, Expiration code of PLT 49-64 OCT 08 2013 WJ
Dannon Company is recalling certain lots of ACTIVIA LIGHT Nonfat Yogurt Strawberry/Banana & Peach Flavors due to the potential for mold.
Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, Inject 1 mL Intramuscularly as directed by physician, Walgreens Specialty Pharmacy, Fresco, TX.
Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone in Ethyl Oleate sterile injection due to concerns of sterility assurance with the specialty pharmacy's independent testing laboratory.
Products were delivered to retail stores/cafes/restaurants throughout California and to AZ, CO, NE, NJ, NY, OR and WA
Almond Biscotti, 1 oz. and 0.5 oz. wrapped in plastic, with ''Enjoy By dates prior to 091614, manufactured by Semifreddi's Inc, Alameda, CA.  Product size and UPC codes  0.5 oz., case of 100 units   758843915936,   1.0 oz., box of 4 units  758843915738 ,   1.0 oz., box of 12 units  758843915950,  1.0 oz., case of 50 units  758843915752,
Semifreddi's Almond Biscotti  and Semifreddi's Chocolate Dipped Almond Biscotti are being recalled due to undeclared allergens, milk and soy; butter did not list milk as a subingredient; lecithin did not list soy as a subingredient.
Chocolate Dipped Almond Biscotti, in various sizes, wrapped in plastic, with ''Enjoy By'' dates prior to 091614, manufactured by Semifreddi's Inc, Alameda, CA.  Product Size and UPC codes:  0.65 oz., case of 100 units  758843915943    0.89 oz., tub of 22 units  758843916001   1.3 oz., box of 4 units   758843915745    1.3 oz., box of 12 units  758843915967    1.3 oz., case of 50 units   758843915905
Nationwide Distribution (US), including the states of CA, NE, GA, and IL.
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
Fancy Mixed Nuts (25lbs), Mixed Nuts (25lbs), and Super King Fancy Mixed Nuts (25lbs)
Fancy Mixed Nuts: LOT2013.09.09  Mixed Nuts: LOT2013.09.12   Super King Fancy Mixed Nuts: LOT2013.08.23
American Nuts is recalling Mixed Nuts because they may contain undeclared wheat allergen.
Sensations Asian Supreme Salad Kit; 220 g/7.8 oz.  Product os USA/Produit des E. U. A.    Taylor Farms,  Salinas, CA 93901
Best Before 2013 SE 26; Batch number WO2013252
Canadian product only - Sensations Spinach salad kit was packed in Sensations Asian Supreme Salad kit. The spinach kit contains feta cheese and milk is not listed on the ingredient statement as the source of the cheese as required by FALCPA.