Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood products, exposed to unacceptable temperature during storage, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Worldwide Distribution: US (Nationwide) including states of: AK, CA, CT, FL, IL, IN, IA, LA, MD, MA, MI, MN, NJ, NY, OH, OK, OR, PA, TN, TX, VA, WA, WV, and Puerto Rico; and countries of: Argentina, Australia, Austria, Belarus, Belgium, Bosnia & Herzegovinia, Brazil, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Libya, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Russia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
SL & SLi Series (Mod 15/18/20/25) Linear Accelerator   Used for radiation therapy treatments of malignant neoplastics diseases.
Customers are resetting the default values outside recommended factory settings.
GOKNUR Organic Frozen/IQF Pomegranate Arils. Packed in 10 kg cases.   Labeling is bilingual and in English, reads in part:''goknur***Product of Turkey***ORGANIC FROZEN/IQF POMEGRANATE ARILS***Production Date 17.10.2012***Lot No 12-15-13-2-1-O***Net Weight (kg) 10***Crop Year 2012***Expiry Date 17.10.2014***Carton No 8721***''.
Lot Code 12-15-13-2-1-O Production Date 17.10.2012  Crop Year 2012  Carton No. 8721
Purely Pomegranate, Inc. is voluntarily recalling certain lots of a pomegranate arils due to public concerns about the Hepatitis A Virus.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language)
Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient.
Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128  12345   (labeling is in foreign language)
Shipped to Distributor, Lab Supply,  Fort Worth Warehouse,  Fort Worth, Texas  who shippedproduct  to the Oklahoma City Zoo.
PURINA TEST DIET: Mod PicoLab Mouse w/12 PPM Ivermectin  Route of Administration: Oral; Name and Address: Richmond Indiana Test Diet, 1050 Progress Drive, Richmond, IN 47374; Product Code 5D5R
A single lot (one 3.065 kg lot) test diet product Mod PicoLab Mouse w/12 ppm Ivermectin was manufactured incorrectly. The Test Diet facility was advised by their customer of a rodent mortality incident and the on-site veterinarian diagnosed Ivermectin toxicity.  Investigation confirmed that an employee manufacturing error resulted in a significantly elevated level of Ivermectin in this feed.
Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-1559-30.
Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, Hawaii and Puerto Rico; and countries of:  Spain, Australia, Canada, Colombia, Japan, Uruguay, Mexico, Estonia, United Kingdom, Denmark, Germany, Spain, Italy, Poland, Ireland Netherlands, France, Sweden, Portugal, Australia, France, Belgium, Switzerland, Norway, Czech Republic, France, Holland, and Luxembourg.
Dental Abutment labeled in part: ''4555 Riverside Drive Palm Beach Gardens, FL 33410 USA  1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to use.***Biomet 3i Dental Iberica S.L.***   Biomet 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support prostheses in edentulous or partially edentulous patients. These are intended for use to support single and multiple tooth prostheses.
All lots of products made since April 1, 2011. Catalog model EDAZ, EDAZx and ILDExxx
Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.
10'' Chocolate Supreme Cake Layers,   NET WT. 20 oz. packed in cases of 12.  Keep Frozen until ready to use.  CSM Bakery Products NA, Inc., Tucker, GA 30084 USA   Product is for institutional use.
Lot #1328702013 All cases stamped with Lot #1328702013 and also showing a USE BY date of JUL/14/14 along with a 24-hour time stamp between 15:00 and 24:00. For example, a case showing ''1328702013 17:36 USE BY JUL/14/14'' is subject to the recall while ''1328702013 02:14 USE BY JUL/14/14'' is not subject to the recall.  Also NOT included in the recall would be a case showing an earlier USE BY date along with Lot # 1328702013. For example, ''1328702013 15:36 USE BY JUL/13/14'' is not subject to the recall.
576 cases each containing 12 - 20 oz. cake layers
Foreign Material - specifically the product has the potential to contain pieces of a red plastic scoop.
Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.
5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015 USA, Product code 2B0089, NDC 0338-0017-38.
Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution.
0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b)  100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation, Deerfield, IL  60015 USA.
Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution.
Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015.  NDC:  0338-1115-04.
Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-1115-04.
Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only.  Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1099-04.
Good Neighbors Specialty Foods Tabouli Salad; 8 oz plastic container; UPC 18561500007 and 14 oz plastic container; 18561500068
Blood Systems, Inc. DBA United Blood Services
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Worldwide Distribution - USA including CA, DC, FL, LA, MA, MO, NC, NJ, NY, TX, VA, WA and Hawaii and Internatially to Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Great Britain (UK), Ireland, Mexico, Poland, Portugal, and Singapore.
ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute)   Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery.
Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number.
Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.
VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the correction factors adjustment on the VITROS Chemistry Systems. It does not have a 510(k) number. Because the WCF slide is a part/ tool, and is not a device used for diagnostic testing, there is no Intended Use statement. The following summary is provided as a description/ explanation of the WCF slide. The WCF slide is a part/ tool used in the reflectometer correction factor adjustment procedure in order to optimize the optical calibration of the VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600 Integrated
An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report TBIL, Bu, Bc, and derived tests results.  The correct assay value is 0.8658.
Blood product, which did not meet acceptable product specifications, was distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood product, mislabeled as to antigen phenotype, was distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Southern California Permanente Medical Group
Blood product, which did not meet the acceptable product specifications, was distributed.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, routine testing/testing performed, interpreted, or documented incorrectly, was distributed.
Blood products, not manufactured in accordance to current Good Manufacturing Practices, were distributed.
Buzzaround XL scooters'    Product Usage:  mobility
GB 116 and GB146 series, with multiple serial numbers
Buzzaround XL scooters' front to rear lockup can become unintentionally disengaged due to possible improper fit of the front alignment cup to the rear alignment screw.
Blood products, which did not meet the acceptable product specifications, were distributed.
Product was distributed in Virginia and Maryland.
Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831***
Lot number: 12052013:03 Expiration date: 06/03/2014
Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
1 distributor in CA. No foreign, military/govt/VA consignees.
Item number T3695, White cheddar jalapeno seasoning powder, 50 lb bags.
All American Seasonings is recalling T3695 White cheddar jalapeno seasoning powder, lots 34577 and 40257 after being notified by Elite spice that there was a potential recall for salmonella in the Jalapeno powder they received.
Worldwide Distribution: US (nationwide) and countries of: Austria, Canada, Germany, Israel, Netherlands, Norway, Sweden, Switzerland, United Kingdom.
FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room  temperature below 86 degrees F (30 degrees C). Use test strips  only within the system operating temperature  range as outlined in your Owner's Booklet.    Meter made in China;  Distributed by Abbott Diabetes Care, Alameda, CA    The FreeStyle mete should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Mete can product inaccurate results.    The FreeStyle Glucose meter is incorporated into the OmniPod insulin Management system (manufactured by Insulet Corporation, Bedford, MA and is intended for subcutaneous delivery of insulin.    Intended to monitor blood glucose from samples taken from the body. IVD use only,
Part number CAT11001-0; all serial numbers
not provided. Device has not been shipped in the last 5 years.
Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with  Free Style test strips lots within expiry.
FreeStyle  Flash  Blood Glucose Monitors System.   Meter made in China;  Distributed by TheraSense,  Alameda, CA    The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Meter can product inaccurate results.    Intended to monitor blood glucose from samples taken from the body. IVD use only,
Catalog Number 17002 NDC 99073-0170-02. All serial numbers
Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry.
Regional; to various grocery stores in Colorado, Wyoming, Nebraska and Kansas. For foreign, military/govt/VA consignees.
FLOUR TORTILLAS: FAJITA 6'' 15 0Z UPC Code 1569602222, HOMESTYLE 8'' 24 OZ UPC Code 1569602221, BURRITO 10'' 28OZ UPC Code 1569602223, GRANDE 12'' 36 OZ UPC Code 1569602224, JUAREZ 8'' 24 OZ UPC Code 1569603337, 8'' RESTAURANT 23 OZ UPC Code 1569602230, 10'' RESTAURANT 28 OZ UPC Code 1569602226.  Packaged in clear poly plastic bags.
Expiration Dates from December 20 to February 27, 2014
Tortillas Mexico is recalling all tortillas with the Expiration Dates from December 20 to February 27, 2014 due to metal detector malfunction during production and therefore potential for metal in product.
CORN TORTILLAS: 18 CT YELLOW/WHITE 18 OZ USPC Code 1569603333, 36 COUNT YELLOW/WHITE 36 OZ USPC Code 1569603335/4, 75 COUNT WHITE CORN 5 LB,USPC Code 1569603331, 100 COUNT WHITE CORN 100 OZ USPC Code 1569603336, 36 COUNT MINI 24 OZ USPC Code 1569603332, 36 COUNT TAQUITO 23 OZ UPC Code 1569603345, 100 COUNT TAQUITO 4 LB UPC Code 1569603346.   Packaged in clear poly plastic bags.
Tortillas Mexico is recalling all tortillas with the Expiration Dates from December 20 to February 27, 2014 because a meatal staple was found by a consumer in a baked tortilla.  Investigation by the Colorado Health Department found the firm's metal detector was not functioning.
WHEAT TORTILLAS: 9 COUNT, 18 OZ, UPC Code 1569602225. Packaged in clear poly plastic bags.
USA Distribution including the states of  FL, NY, OR, IL, PA, MO and NJ.
Gibralt Spine System Polyaxial Screw   Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.
The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy.
Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of   Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.
Gender Solutions'' Natural-Knee Flex System: N-K FLEX MBACK SZ 0 PAT  N-K FLEX MBACK SZ 1 PAT  N-K FLEX MBACK SZ 2 PAT
A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial  light for six years prior to inert packaging and sterilization of the device.
Natural-Knee N-K II DOMED ALL-POLY PAT, SZ0  N-K II DOMED ALL-POLY PAT, SZ1
MOST Options'' System (MOST) HINGED TIB INS SZ 1 16MM  HINGED TIB INS SZ 4 6MM M  HINGED TIB INS SZ 4 9MM M  HINGED TIB INS SZ 4 16MM  MOST PROX TIB INS 6MM
Natural-Knee II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN  CONG TIB INS SZ1/2 11MM U  CONG TIB INS SZ1/2 13MM U  CONG TIB INS SZ3/4 9MM UN  CONG TIB INS SZ3/4 11MM U  CONG TIB INS SZ3/4 13MM U  CONG TIB INS SZ 5/6 9MM U  CONG TIB INS SZ5/6 11MM U  CONG TIB INS SZ5/6 13MM U
Natural-Knee II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm  UNI ALL-POLY TIB SZ 1-9mm
Natural-Knee/Apollo'' Knee: M/B PAT SZ0 NATURAL-KNEE  M/B PAT SZ1 NATURAL-KNEE  M/B PAT SZ2 NATURAL-KNEE
Natural-Knee Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1  SF-CON TIB INS RT SZ1/2 9  SF-CON TIB INS RT SZ3/4/5
Natural-Knee II System ULTRA CONG INS LT SZA/9MM  ULTRA CONG INS LT SZA/13M  ULTRA CONG INS LT SZA/19M  ULTRA CONG INS RT SZA/9MM  ULTRA CONG INS RT SZA/11M  ULTRA CONG INS RT SZA/13M  ULTRA CONG INS RT SZA/19M  ULTRA CONG INS LT SZB/13M  ULTRA CONG INS LT SZB/16M  ULTRA CONG INS RT SZB/19M  ULTRA CONG INS RT SZB/22M  NKII ROT PLTFM U/C INS, 9  NKII ROT PLTFM U/C INS, 1  NKII ROT PLTFM U/C INS, 1  NKII ROT PLTFM U/C INS, 1  NKII ROT PLTFM U/C INS, 1  NKII ROT PLTFM U/C INS, 1  NKII ROT PLTFM U/C INS, 1  NKII ROT PLTFM U/C INS, 1  NKII ROT PLTFM U/C INS, 1  NKII ROT PLTFM U/C INS, 1  NKII ROT PLTFM U/C INS, 1  NKII ROT PLTFM U/C INS, 1  NKII ROT PLTFM U/C INS, 1  NKII ROT PLTFM U/C INS, 1  ALL POLY CONG TIB LT SZ00  ALL POLY CONG TIB LT SZ0/  ALL POLY CONG TIB LT SZ0/  ALL POLY CONG TIB RT SZ0/  ALL POLY CONG TIB RT SZ0/  ALL POLY CONG TIB LT SZ1/  ALL POLY CONG TIB LT SZ1/  ALL POLY CONG TIB RT SZ1/  ALL POLY CONG TIB RT SZ1/  ALL POLY CONG TIB RT SZ1/  ALL POLY CONG TIB LT SZ2/  ALL POLY CONG TIB LT SZ2/  ALL POLY CONG TIB LT SZ2/  ALL POLY CONG TIB LT SZ2/  ALL POLY CONG TIB RT SZ2/  ALL POLY CONG TIB RT SZ2/  ALL POLY CONG TIB RT SZ2/  ALL POLY CONG TIB LT SZ3/  ALL POLY CONG TIB LT SZ3/  ALL POLY CONG TIB LT SZ3/  ALL POLY CONG TIB RT SZ3/  ALL POLY CONG TIB RT SZ3/  ALL POLY CONG TIB RT SZ3/  ALL POLY CONG TIB LT SZ4/  ALL POLY CONG TIB LT SZ4/  ALL POLY CONG TIB RT SZ4/  ALL POLY CONG TIB RT SZ4/  ALL POLY CONG TIB RT SZ5/  PS TIB INS RT SZ1/2 16MM  PS TIB INS RT SZ1/2 19MM  PS TIB INS LT SZ00/0 19MM  PS TIB INS RT SZ00/0 11MM  PS TIB INS RT SZ00/0 16MM
Natural-Knee II Constrained Knee System NKII CCK TIB INS SZ00/0-L  NKII CCK TIB INS SZ1/2-LF  NKII CCK TIB INS SZ3-5 -L  NKII CCK TIB INS SZ00/0-R  NKII CCK TIB INS SZ3-5 -R  NKII CCK TIB INS SZ1/2-LF  NKII CCK TIB INS SZ3-5 -L  NKII CCK TIB INS SZ00/0-R  NKII CCK TIB INS SZ1/2-RT  NKII CCK TIB INS SZ3-5 -R  NKII CCK TIB INS SZ00/0-L  NKII CCK TIB INS SZ1/2-LF  NKII CCK TIB INS SZ3-5 -L  NKII CCK TIB INS SZ00/0-R  NKII CCK TIB INS SZ3-5 -R  NKII CCK TIB INS SZ1/2-LF  NKII CCK TIB INS SZ3-5 -L  NKII CCK TIB INS SZ00/0-R  NKII CCK TIB INS SZ3-5 -R  NKII CCK TIB INS SZ00/0-L  NKII CCK TIB INS SZ1/2-LF  NKII CCK TIB INS SZ00/0-R  NKII CCK TIB INS SZ1/2-RT  NKII CCK TIB INS SZ1/2-LF  NKII CCK TIB INS SZ3-5 -L  NKII CCK TIB INS SZ00/0-R  NKII CCK TIB INS SZ1/2-RT  NKII CCK TIB INS SZ00/0-L  NKII CCK TIB INS SZ00/0-R
Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ  N-K II CONS PS TIB INS SZ  N-K II CONS PS TIB INS SZ  N-K II CONS PS TIB INS SZ  N-K II CONS PS TIB INS SZ  N-K II CONS PS TIB INS SZ  N-K II CONS PS TIB INS SZ  N-K II CONS PS INS TIB SZ  N-K II CONS PS TIB INS SZ  N-K II CONS PS TIB INS SZ  N-K II CONS PS TIB INS SZ  N-K II CONS PS TIB INS SZ  N-K II CONS PS TIB INS SZ  N-K II CONS PS TIB INS SZ
Apollo'' Knee System: APOLLO PATELLA SZ0 28MM R
Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO  CONG TIB INS SZ0/22MM APO  CONG TIB INS SZ1/9MM APOL  CONG TIB INS SZ1/11MM APO  CONG TIB INS SZ1/19MM APO  CONG TIB INS SZ2/13MM APO  CONG TIB INS SZ2/19MM APO  CONG TIB INS SZ3/9MM APOL  CONG TIB INS SZ3/13MM APO
Apollo'' Knee System: PS TIB INS SZ0/16MM APOLL  PS TIB INS SZ0/19MM APOLL  PS TIB INS SZ0/22MM APOLL  PS TIB INS SZ1/16MM APOLL  PS TIB INS SZ2/16M APOLLO  PS TIB INS SZ2/22MM APOLL  PS TIB INS SZ3/16MM APOLL  PS TIB INS SZ3/19MM APOLL  PS TIB INS SZ4/9MM APOLLO  PS TIB INS SZ4/11MM APOLL  PS TIB INS SZ4/13MM APOLL  PS TIB INS SZ4/16MM APOLL  PS TIB INS SZ4/19MM APOLL  PS TIB INS SZ4/22MM APOLL  PS TIB INS SZ5/9MM APOLLO  PS TIB INS SZ5/19MM APOLL
Apollo'' Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER  SZ1-11MM AK CCK TIB INSER  SZ1-16MM AK CCK TIB INSER  SZ1-22MM AK CCK TIB INSER  SZ1-30MM AK CCK TIB INSER  SZ2-11MM AK CCK TIB INSER  SZ2-13MM AK CCK TIB INSER  SZ2-16MM AK CCK TIB INSER  SZ2-22MM AK CCK TIB INSER  SZ2-30MM AK CCK TIB INSER  SZ3-16MM AK CCK TIB INSER  SZ3-22MM AK CCK TIB INSER  SZ3-25MM AK CCK TIB INSER  SZ4-13MM AK CCK TIB INSER  SZ4-16MM AK CCK TIB INSER  SZ5-11MM AK CCK TIB INSER
Natural-Knee II System: POLY ULTRA TIB LT SZ00/9M  POLY ULTRA TIB LT SZ0/9MM  POLY ULTRA TIB LT SZ0/19M  POLY ULTRA TIB RT SZ0/13M  POLY ULTRA TIB RT SZ0/16M  ALL POLY ULTRA TIB LT SZ1  ALL POLY ULTRA TIB RT SZ1  ALL POLY ULTRA TIB LT SZ2  ALL POLY ULTRA TIB LT SZ2  ALL POLY ULTRA TIB RT SZ2  ALL POLY ULTRA TIB LT SZ3  ALL POLY ULTRA TIB RT SZ3  ALL POLY ULTRA TIB RT SZ5
USA Nationwide Distribution including Puerto Rico.
Mar Cor Purification Millenium HX Portable Reverse Osmosis System.  Model 3025975.       Product Usage:   Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment..
High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment.
Denlase: Diode Laser Therapy System and  Penlase: Dental Laser Therapy System surgical powered.    Surgical powered Laser instruments.
Denlase and Penlase Dental  Laser Systems.
Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2).  For example, the user manual did not contain calibration procedures for Denlase or Penlase Lasers
Worldwide Distribution - USA (nationwide) and Internationally to Taiwan.
Product Brand Name(s): Alere Triage TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B.   25 individually pouched devices in a labeled kit box.    Indications for use: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography/ Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.
Catalog Number 94400, Lots W56013B and W56035B
Alere San Diego, Inc. is initiating a recall of the Alere Triage TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation has shown that these lots have a frequency of false negative results for PCP (Phencyclidine) that is higher than the frequency shown in the package insert. If you have questions about previously reported results.
Blood products, collected from a donor who was previously deferred, were distributed.
Nationwide distribution to MN, AR, MA, TX, NJ, WV, GA, CA, PA, OH, MI, WI, TN, NY, KS, CT, NY, MO, IL, IN, OR, IA, and WA.
syngo Dynamics  Picture Archiving and Communication System (PACS).  Model numbers 10091804, 10091805, 10091806, 10091807, 10091673
Model nos.10091804, 10091805, 10091806, 10091807, 10091673.  syngo Dynamics Version 9.5 using Sensis integration.
Potential patient data mixup.  Improper error handling could allow for two different patients to be displayed in syngo Dynamics.  Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis.
Nationwide Distribution-including the states of AL, CA, CO, CT, DE, FL, KY, MD, MI, MN, MO, NC, NY, OH, OR, PA, TN, UT, VA & WA.
Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069.   The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage.
The firm was notified by a customer of a cracked spring in the handle of the RCD1 device.
Creation Special Snack Mix; 25 lb. cardboard carton
Due to the lack of the ingredient statement the firm failed to declare the following direct allergens: peanuts, tree nuts, soy, wheat, and yellow #5. The products also lack the declaration that they are packaged in a facility that handles milk and eggs.
Bar Star Snack Mix; 25 lb. cardboard carton
Distributed USA (nationwide) and Canada.
MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14.   Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS).
Potential for erroneous result reporting.
Product was distributed in AZ, FL, IA, IL, IN, MI, MN AND WI.
4 oz. Heart - Shaped Box of Assorted Chocolates
Worldwide Distribution and in the state of TX
Medline Sterile Foley Catheter 14 fr 5 cc  12 pieces   model number DNYD11914    Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way &#38; 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.
The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.
Curion CuriStay Nelaton   CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL    Product Usage:  Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way &#38; 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.
SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc    Product Usage:  Usage:  Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way &#38; 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.
JMS, Japan, 3 WAY, 20 FR 10 mL    Product Usage:  Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way &#38; 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.
'TORAY' Hydrocoat Foley Catheter 12 x10  4.00 mm Fr x mL    Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way &#38; 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.
SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc   Product Usage:  Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way &#38; 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes.
Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B.  The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England.   Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
Some of the discs may not be impregnated with the antibiotic.
Worldwide Distribution: US (nationwide) to states of: CO, IN, MA, NJ, NC, OH, PA, TX, and VA; and countries of: Algeria,France, Germany, Poland, Russia, and Taiwan.
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3.   The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated (Respiratory and Cardiac) acquisitions in patients of all ages.
GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your Optima CT580 or Discovery CT590RT scanner.   A potential hazardous situation may occur during a CT head scan causing a novel and rare artifact that may hide pathology. When using the head and large head SFOV, which applies the Iterative Bone Option (IBO), the image clarity between the cranial -brain interface, may not be clinically acceptable. The artifact degrades image quality at the boundary between the cranium and brain surface, but does not affect the bone image quality. No injuries have been reported to date.
Worldwide Distribution - USA including CA, CT, FL, GA, IL, IN, LA, MI, MN, MO, NC, NY, PA, TN, TX, and Internationallly to United Arab Emirates (UAE), Taiwan, Thailand, Malaysia, Belgium, Japan, Mexico, and Canada.
Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2'' connector, 14.5'' (37 cm) long   The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae.
Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2'' connector, 14.5'' (37 cm) long, with X Coating   The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2'' connector, 15'' (38 cm) long   The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2'' connector, 15'' (38 cm) long   The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2'' connector, 15'' (38 cm) long, with X Coating   The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2'' flare   The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2'' flare   The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
Philips Medical Systems North America Inc.
Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs).    Product Usage:  The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads.    Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home).
5075 units total (2724 units in the US and 2351 units outside the US)
Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency.
Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.
Part 475620 Intramedullary Bone Saw CAM Assembly  Size 12mm,     A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur.
Incorrect labeling on specific lots of the Intramedullary Bone Saw.The Saw Blade Assembly was identified as CAM Assembly.
Part 475625, Intramedullary Bone Saw, Cam Assembly  Size 13 mm,     The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly.
Part 475630, Intramedullary Bone Saw, Cam Assembly  Size 14 mm,       The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
Worldwide Distribution - US Distribution including the states of AL, CA, CO, WA DC, FL, GA, HI, KS, MD, ME, MI, MS, NC, NM, NY, PA, TX, VA, WA and WI., and the countries of  Australia, Austria, Canada, France, Germany, India, Italy, Ireland, Japan, Malaysia, Netherlands, Norway, Switzerland, Taiwan and United Kingdom.
Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389.   The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms: -Unresponsiveness -Absence of normal breathing If in doubt, apply the pads. The HeartStart FR3 is intended for adults and children over 55 pounds (25 kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child's age or weight, do not delay treatment.
251 units total (128 in USA and 123 untils outside USA)
Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact points that hold the board in place. In the event the PCB becomes separated from the electrical contact points, the AED may not be ready to deliver a shock in the event of an emergency.
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and the states of  AL, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MS, MO, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV and WI,and the countries of United Arab Emirates, Austria, Australia, Azerbaijan, Belgium, Belgrade, Bahrain, Canada, Switzerland, Cameroon, China, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Great Britain, Greece, Guyana, Croatia, Hong Kong, Hungary, Ireland, Israel, India, Iraq, Italy, Japan, Jordan, Kenya, Kuwait, Lebanon, Latvia, Libya, Morocco, Serbia, Malaysia, Martinique, Nigeria, Netherlands, Norway, Oman, Panama, French Polynesia, Philippines, Poland, Portugal, Qatar, Reunion, Russia, San Salvador, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, San Marino, Thailand, Trinidad, Tunisia, Turkey, Venezuela, Yemen and Zambia
Rusch Brochopart and Rusch Brochopart White   The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The endobronchial tube allows ventilation and selective inflation or deflation of either lung.
The product may fail to achieve seal of right lung due to the cuff inflating to one side
Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For Manufacturing, Processing, or Repacking, Delta Synthetic Co., Ltd. 15, Minsheng St., Tucheng Dist., New Taipei City, 23679, Taiwan (ROC), NDC 60203-1001
Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin.
Product was distributed in Western WA and Western OR.
Starbuck's brand Greek Yogurt Raspberry & Lemon Parfait; 6.1 oz single serve plastic cups, sold as individual unit. Finished product label is affixed to the top of the cup; nutritional labeling is located on the side of the cup, along with the printed code which appears on a white sticky label.  UPC 6211198649.
''Enjoy by 03 05'', which represents March 5th, 2014.
Gretchen's Shoebox Express is recalling Greek Yogurt Raspberry & Lemon Parfait cups sold under the Starbucks brand due to undeclared egg.
Worldwide Distribution: US (nationwide) including states of: AL, AK, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NM, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, and WV; and countries of: Australia, Austria, Belgium, Canada, Chili, Ecuador, Egypt, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Korea Rep, Malaysia, Netherlands, New Zealand, Norway, Peru, Philippines, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey and United Kingdom.
Philips Model EPIQ 5 Ultrasound System.  Intended for diagnostic ultrasound imaging and fluid flow analysis.   Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206    EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis.
All systems below software v1.1.2 Which includes software v1 and  v 1.1 (All lot codes shipped prior to 2/28/2014).
489 total =227 units in US and 262 units Internationally (no Canadian consignees)
A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System.  The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom  Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated by 25-75%, depending on the scale value.
Philips Model EPIQ 7 Ultrasound System.  Intended for diagnostic ultrasound imaging and fluid flow analysis.   Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206    EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis.
1267 total :670 units in US and 1267 units Internationally (which includes 11 units in Canada)
Worldwide Distribution - USA Nationwide in the states of FL, NC, IA, AL, IL, TX and the countries of  Argentina.
DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017     Product Usage:  Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others
Worldwide Distribution: US (nationwide) to states of: TN, MA, CA, TX, MD,FL, MS, IL, and PA; and to countries of: France, Thailand, Egypt, Mexico, Kuwait, India, Austria,Japan, Sweden, Peru, United Kingdom, Philippines,The Netherlands, China,, UAE,Israel, Germany, Italy.
Halogen Lamp component  in RetCam 3 System -    Clarity Medical Systems, Inc;  Pleasanton, CA.    General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP.
One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could result in damage limited to the internal electrical components inside the RetCam 3 computer module.
Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.
Misbranded Reagent Red Blood Cells were distributed.
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186.  NDC 68968-5554-3.
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patches per box, Rx Only.Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5555-3.
CA,CO, CT, GA, HA, KY, MA, ME, MI, MN, NC, NH, NV, NY, OH, OK, OR, PA, PA, SC, SD,  TN, UT, VT, WA
High Mowing Organic Sprouting Seeds Ancient Eastern Blend , 4 oz. resealable plastic bag UPC Code: 872724005445
Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP,  75mg/5mL, 100 ml, NDC 0574-0129-01
Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml.
Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10
Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
Stryker Instruments Div. of Stryker Corporation
US Distribution including the states of  NV, CA, WA, TN, OR, SD, ID, IN and CO., and Internationally to Malaysia
2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub.   ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only    It is used for ENT procedures and functions by means of rotation when adapted to a handpiece and console. Through the rotation, the necessary tissue is resected as required by the user. The blade housing has an etching line guide that starts with a straight line and along with a scale from 1cm to 7cm in 1cm increments that serves the doctor as a guide by indicating how far the device is being introduced into the surgical area.
Stryker Instruments is voluntarily recalling the single use 2.5MM Aggressive Blade because the line on the affected part (P/N 5290-928-000, Lot #13280CG2) was a straight line without a number scale or logo. The line required for this part number includes a number scale that goes from 1cm  7cm.