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U.S. Department of Health and Human Services

Enforcement Report - Week of August 13, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs Risperdal CONSTA (risperiDONE), 25 mg Dose Pack, Rx Only, Single Use Only Janssen Pharmaceuticals Inc., Titusville, NJ 08560 NDC 50458-306-11 Vial - 4212AAP1, Kit - 309316, Exp. 07/15 Class II Non-Sterility: Janssen is recalling one lot of Risperdal CONSTA (risperiDONE) due to a sterility failure in a stability sample Janssen Pharmaceuticals, Inc.
Devices Latex Dental Dams labeled as Non-Latex Dental Dams Model/Catalog number 1884-10840 Lot number 103G2 Exp Date 2016/10 Class II Coltène/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging. Coltene Whaledent Inc
Biologics Rejuvesol Red Blood Cell Processing Solution, 50 ml. Sterile Rx Intended only for use in the extracorporeal rejuvenation of a unit of red blood cell concentrate (RBC}. Part Number: 7012 Lot Code/Exp. Date: J13026A December 31, 2015; Class II Rejuvesol Red Blood Cell Processing Solution, with a potentially compromised container closure seal, was distributed. Citra Labs LLC.
Food KIND HEALTHY GRAINS Maple Pumpkin Seed Bar, 35g, packaged in a purple, black and transparent wrapper. Sold individually or packaged in a box of 5. Lot Codes: TC14034A, TC14034B, TC14035A, TC14035B, TC14036A, TC14036B, TC14088A, TC14088B, TC14088C, TC14090A, TC14090B, TC14090C Class I The firm is recalling all lots of the following products due to the potential presence of peanut protein: Kind Maple Pumpkin Baked Bar,Strong & Kind Honey Mustard, Strong & Kind Thai Sweet Chili, Strong & Kind Roasted Jalapeno, Strong & Kind Hickory Smoked, Strong & Kind Honey Smoke BBQ Bars KIND, LLC
Food STRONG & KIND Honey Smoked BBQ Almond Protein Bar, 45g, packaged in a red, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12. Lot Codes: TC14048B1, TC14048C1, TC14069A1, TC14069B1, TC14069C1, TC14070A1, TC14070B1, TC14101A1, TC14101B1, TC14101C1, TC14102A1, TC14102B1, TC14102C1 Class I The firm is recalling all lots of the following products due to the potential presence of peanut protein: Kind Maple Pumpkin Baked Bar,Strong & Kind Honey Mustard, Strong & Kind Thai Sweet Chili, Strong & Kind Roasted Jalapeno, Strong & Kind Hickory Smoked, Strong & Kind Honey Smoke BBQ Bars KIND, LLC
Food STRONG & KIND Roasted Jalapeno Almond Protein Bar, 45g, packaged in a green, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12. Lot Codes: TC14049C1, TC14050A1, TC14072C1, TC14073A1, TC14073B1, TC14073C1, TC14099A1, TC14099B1, TC14099C1 Class I The firm is recalling all lots of the following products due to the potential presence of peanut protein: Kind Maple Pumpkin Baked Bar,Strong & Kind Honey Mustard, Strong & Kind Thai Sweet Chili, Strong & Kind Roasted Jalapeno, Strong & Kind Hickory Smoked, Strong & Kind Honey Smoke BBQ Bars KIND, LLC
Food STRONG & KIND Honey Mustard Almond Protein Bar, 45g, packaged in a yellow, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12. Lot Codes: TC14049A1, TC14049B1, TC14070B1, TC14070C1, TC14071A1, TC14071B1, TC14105B1, TC14105C1, TC14106A1, TC14106B1, TC14106C1, TC14107A1 Class I The firm is recalling all lots of the following products due to the potential presence of peanut protein: Kind Maple Pumpkin Baked Bar,Strong & Kind Honey Mustard, Strong & Kind Thai Sweet Chili, Strong & Kind Roasted Jalapeno, Strong & Kind Hickory Smoked, Strong & Kind Honey Smoke BBQ Bars KIND, LLC
Food STRONG & KIND Hickory Smoked Almond Protein Bar, 45g, packaged in a grey, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12. Lot Codes: TC14048A1, TC14048B1, TC14074A1, TC14074B1, TC14074C1, TC14076A1, TC14102C2, TC14104A1, TC14104B1, TC14104C1, TC14105A1 Class I The firm is recalling all lots of the following products due to the potential presence of peanut protein: Kind Maple Pumpkin Baked Bar,Strong & Kind Honey Mustard, Strong & Kind Thai Sweet Chili, Strong & Kind Roasted Jalapeno, Strong & Kind Hickory Smoked, Strong & Kind Honey Smoke BBQ Bars KIND, LLC
Food STRONG & KIND Thai Sweet Chili Almond Protein Bar, 45g, packaged in a purple, black and transparent wrapper. Sold individually or packaged in a box of 4 or 12. Lot Codes: TC14049B1, TC14049C1, TC14071C1, TC14072A1, TC14072B1, TC14072C1, TC14100A1, TC14100B1, TC14100C1, TC14101A1 Class I The firm is recalling all lots of the following products due to the potential presence of peanut protein: Kind Maple Pumpkin Baked Bar,Strong & Kind Honey Mustard, Strong & Kind Thai Sweet Chili, Strong & Kind Roasted Jalapeno, Strong & Kind Hickory Smoked, Strong & Kind Honey Smoke BBQ Bars KIND, LLC
Drugs Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410, NDC 25682-001-01, UPC 3 25682-001-01 6. Lots: 10002-1, 00006-1, Exp 08/14; 10003A, Exp 11/14; 10004A, Exp 02/15; 10005A, 10005AR, 10007A, 10006A, Exp 07/15; and 10008A, Exp 08/15 Class I Presence of Particulate Matter: Product failed the appearance for the presence of visible particles under labeled storage condition. Alexion Pharmaceuticals, Inc.
Devices KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outside the US and Canada) --- A permanently installed diagnostic x-ray system composed of 3 main components: an operator console, U-Arm assembly with x-ray tube including a collimator, and a stationary generator. Service Code 1534 Class II A control system failure may cause the U-Arm to move downward unexpectedly when the Radiology Technologist is positioning the equipment using the "Up" or "Down" control buttons. Downward movement occurs at three times the normal rate of speed and will continue until the device control button is released, the Emergency Stop button is activated or the equipment Bump Sensor contacts an object. Carestream Health Inc.
Biologics Red Blood Cells Leukocytes Reduced W036813221954; Class II Blood product, incorrectly determined to be negative for the Jk(a) antigen, was distributed. OneBlood, Inc.
Biologics Source Plasma FD0841959; Class III Blood product, collected from a donor who had no responses to medical history questions documented, was distributed. DCI Biologicals LLC
Biologics Source Plasma NG0327471; NG0328013; NG0328785; NG032890; NG0329572; NG0330684; Class II Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed. DCI Biologicals, LLC
Biologics Red Blood Cells Leukocytes Reduced W069113102395; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Mississippi Blood Services Inc.
Biologics Blood and Blood Products for Reprocessing W069113102395; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Mississippi Blood Services Inc.
Biologics Red Blood Cells Leukocytes Reduced W035212339643K; Class II Blood products, collected from a donor whose health history was inadequately determined, were distributed. Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc
Biologics Cryoprecipitated AHF W035212339643K; Class II Blood products, collected from a donor whose health history was inadequately determined, were distributed. Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc
Biologics Blood and Blood Products for Reprocessing W035212339643K; Class III Blood products, collected from a donor whose health history was inadequately determined, were distributed. Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc
Food Traditional Hummus sold under the Archer Farms brand and packaged in either a transparent plastic tub or a white plastic tub with a net weight respectively of 10 oz (283 g) or 2 lb. All products with the "Use By" date of JUN/11/2014 Class I Lansal, Inc. (d.b.a. Hot Mama's Foods) is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes. Hot Mama's Foods
Food Roasted Garlic Hummus sold under the Archer Farms brand and packaged in a transparent plastic tub with a net weight of 17 oz (1 lb. 1 oz). All products with the "Use By" dates of JUN/9/2014 and JUN/12/14 Class I Lansal, Inc. (d.b.a. Hot Mama's Foods) is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes. Hot Mama's Foods
Food Roasted Red Pepper Hummus sold under the Archer Farms brand and packaged in a transparent plastic tub with a net weight of 17 oz (1 lb. 1 oz). All products with the "Use By" date of JUN/12/2014 Class I Lansal, Inc. (d.b.a. Hot Mama's Foods) is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes. Hot Mama's Foods
Food Chipotle Hummus sold under the Giant Eagle Market District brand and packaged in a transparent plastic tub with a net weight of 8 oz (227 g). All products with the "Use By" dates of MAY/7/2014 and MAY/14/14 Class I Lansal, Inc. (d.b.a. Hot Mama's Foods) is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes. Hot Mama's Foods
Food Garlic Hummus sold under the Giant Eagle Market District brand and packaged in a transparent plastic tub with a net weight of 8 oz (227 g). All products with the "Use By" dates of MAY/7/2014 and MAY/14/14 Class I Lansal, Inc. (d.b.a. Hot Mama's Foods) is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes. Hot Mama's Foods
Food Edamame Hummus sold under the Trader Joe's brand and packaged in a transparent plastic tub with a white lid and with a net weight of 8 oz (227 g). All products with the "Use By" dates of APRIL/28/2014, APRIL/29/14, and MAY/9/14 Class I Lansal, Inc. (d.b.a. Hot Mama's Foods) is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes. Hot Mama's Foods
Food 5 Layer Fiesta Dip sold under the Trader Joe's brand and packaged in a transparent plastic tub with a net weight of 11.5 oz (326 g) or 24 oz. All products with the "Use By" dates of APRIL/15/2014, Class I Lansal, Inc. (d.b.a. Hot Mama's Foods) is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes. Hot Mama's Foods
Food Spicy Yellow Lentil Hummus sold under the Eat Well Embrace Life brand and packaged in a transparent plastic tub with a net weight of 10 oz. All products with the "Use By" dates of JUN/10/14 E and JUN/12/14 E Class I Lansal, Inc. (d.b.a. Hot Mama's Foods) is recalling approximately 14,860 pounds of hummus and dip products due to concerns about possible Listeria monocytogenes. Hot Mama's Foods
Drugs Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us All lot numbers and exp dates Class II Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Medical Supply Liquidators Llc
Drugs Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial. For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us All lot numbers and exp dates Class II Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Medical Supply Liquidators Llc
Drugs BCAA 4% Branched Chain Amino Acid Injection USP, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us All lot numbers and exp dates Class II Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Medical Supply Liquidators Llc
Drugs Vitamin B12 Cyanocobalamin Injection USP 1000 mcg/ml, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us All lot numbers and exp dates Class II Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Medical Supply Liquidators Llc
Drugs Vitamin B6 Pyridoxine HCL for Injection USP, 100 mg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose 30 ml vial, manufactured by: CB Inc. for Sunshine Labs, www. sunshinelabs.us. All lot numbers and exp dates Class II Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Medical Supply Liquidators Llc
Drugs Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml, 10 ml vial and 30 ml vial, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. All lot numbers and exp dates Class II Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Medical Supply Liquidators Llc
Drugs MIC Injection USP, Sterile, 10 ml vial and 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us All lot numbers and exp dates Class II Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Medical Supply Liquidators Llc
Drugs Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ Use, Multiple Dose Vial. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. All lot numbers and exp dates Class II Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Medical Supply Liquidators Llc
Drugs Vitamin B12 Cyanocobalamin with MIC Injection USP 1000 mcg/ml, packaged in 10 ml vials and 30 ml vials, Sterile, for IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. All lot numbers and exp dates Class II Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Medical Supply Liquidators Llc
Drugs B Complex for Injection USP with Methylcobalamin 1000 mcg/ml, Sterile, for IM or Deep SQ use, multiple dose vial, packaged in 10 ml vials and 30 ml vials. Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. All lot numbers and exp dates Class II Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Medical Supply Liquidators Llc
Drugs Vitamin B12 Hydroxocobalamin Injection USP 1000 mcg/ml, Sterile, 30 ml vial, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. All lot numbers and exp dates Class II Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Medical Supply Liquidators Llc
Drugs Lipo 8 Injection USP 200 mg/ml, packaged in 30 ml vials, Sterile, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. All lot numbers and exp dates Class II Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Medical Supply Liquidators Llc
Drugs G.A.C. 375 Injection USP, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. All lot numbers and exp dates Class II Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Medical Supply Liquidators Llc
Drugs L-Carnitine Injection USP 100 mg/ml, packaged in 30 ml vials, Sterile, For IM or Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. All lot numbers and exp dates Class II Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Medical Supply Liquidators Llc
Drugs Glutathione Injection USP, 200 mg/ml, packaged in 30 ml vials, Sterile, For IM of Deep SQ Use, Multiple Dose Vial, Manufactured by: CB Inc. for Sunshine Labs, www.sunshinelabs.us. All lot numbers and exp dates Class II Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer Medical Supply Liquidators Llc
Food Beirut Lift Turnips Pickles, Net Wt. 24.66 oz., 700g, Imported & Distributed By: Baroody Import Inc., 1500 B Main Ave. Clifton, NJ 07011, N DC #642036014141 in a sealed glass jar. None Class III Beirut Lift Turnip Pickles contains undeclared FD & C Red #40 and unallowable dye 45170 Rhodamine B - Basic Violet 10. Baroody Imports Inc.
Biologics Medi-Temp Blood/Fluid Warming Cassette, Stryker Medical, 3800 E. Centre Avenue, Portage, MI 49002 Model # D25310CE; Lot #'s: M0112, M0113, M0114, M0212, M0213, M0214, M0214, M0314, M0412, M0413, M0414, M0512, M0514, M0514, M0612, M0614, M0712, M0713, M0713, M0714, M0714, M0812, M0814, M0814, M0914, M1012, M1014, M1112, M1113, M1114, M1213, M1213, M1214, M1313, M1313, M1412, M1413, M1413, M1512, M1513, M1513, M1611, M1612, M1613, M1711,  ...
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Class II Blood/Fluid Warmer Cassettes, associated with complaints in regards to malformed threads on the female luer fitting of specific models, were distributed. Stryker Medical Division of Stryker Corporation
Devices INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc. Lot Numbers: 53901201, 53801303, 53801303-1, 54601201, 54601201-1 Class III Carestream manufacturing identified an incorrect orientation of the indicator dot on dental intraoral film packet labeling. The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the film. This issue may cause some confusion for the dental practitioner if the processed film is placed on the view box by referencing the film's raised dot. The result is the image orientation will be rotated 180 degrees. Carestream Health Inc.
Devices Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc. Lot Numbers: 33301201, 33301202, 33301203, 333012 part unknown, 34301501 Class III Carestream manufacturing identified an incorrect orientation of the indicator dot on dental intraoral film packet labeling. The Indicator Dot on the film packet's outer printed paper labeling was incorrectly positioned relative to the location of the raised dot on the film. This issue may cause some confusion for the dental practitioner if the processed film is placed on the view box by referencing the film's raised dot. The result is the image orientation will be rotated 180 degrees. Carestream Health Inc.
Devices SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System. Lot# 38479172 and 39181172 Class II Complaints of failed calibration. Siemens Healthcare Diagnostics, Inc
Devices SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur CP System. Lot# 38059172 and 39463172 Class II Complaints of failed calibration. Siemens Healthcare Diagnostics, Inc
Devices PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data. Product Code: 5002-0500; Software Versions, 1.4 and 1.6 Class II Potential for demographic information and test result to be mismatch. PerkinElmer Health Sciences, Inc.
Devices Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS. Serial Numbers: 20810001 through 20810148 Class II Risk of incorrect results from samples prepared with Panthera-Puncher 9 PerkinElmer Health Sciences, Inc.
Devices Boston Scientific ENDOTAK RELIANCE® SG, transvenous defibrillation lead, Models 0180 & 0292, Sterile EO. Product Usage: The ENDOTAK RELIANCE leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for automatic implantable cardioverter defibrillator (AICD) systems. Model 0180 s/n 310735 & 310892. Model 0292 s/n 130450, & 309339. Class II A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads revealed a suspected test data recording error. Specifically, some test results were recorded as "failed" without any other indication of failure. There are no reported injuries from the devices. Boston Scientific CRM Corp
Devices ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment. ExacTrac Version 6.0.4; Model/Catalog Numbers: 1) 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE; 2) 20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE; 3) 20835C EXACTRAC 6.0 IR MONITORING SOFTWARE; 4) 20853C EXACTRAC 6.0 X-RAY LIMITED SOFTWARE; 5) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0  ...
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Class II When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position. Brainlab AG
Devices Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System, Model 55-000011, consisting of the control unit, hand-grip, flexible shaft, trocars/obturators, sleeves, valves, and blades. Instructions for Use V. 02.08.2012 that was provided with control units bearing the following serial numbers: 4861300-002, 6283800-002, 6283800-004, 6283800-010, 6283800-023, 6823800-045, 6283800-008, 6283800-011, 6283800-013, 7010201-017, 6283800-014, 6283800-016, 6283800-017, 6283800-019, 6283800-020, 6283800-021, 6283800-022, 6283800-029, 6283800-024, 6283800-026, 6283800-027, 6283800-030, 6283800-031, 6283800-034, 6283800-037, 6283800-038, 6283800-039, 6283800-040, 6283800-042, 6283800-043, 6283800-044, 6283800-046, 6283800-047, 6283800-048,  ...
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Class III Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications. Market-Tiers Inc
Devices RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730. Product Code: 76730, Lot number: 307505. Class III Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is correct, however the expiration date incorrectly indicates that the product is expired. Teleflex Medical
Devices VIDAS TPSA, in vitro diagnostic, for use as an automated quantitative measurement of prostate specific antigen levels in human serum or plasma. Lot 1001904130 Class II Product is not approved or authorized for distribution in the US. BioMerieux SA
Food Simply Enjoy Chocolate Chip Walnut Cookies, 7oz. Use by date Nov 5 2014, UPC # 688267135132, lot#140509AR. This product was on SO#27571. DPI ref-32722125 Class II Recent tests show that the "Simply Enjoy Chocolate Chip Walnut Cookies", Use by date Nov 5 2014, contain undeclared Macademia Nuts which could run the risk of serious or life-threatening allergic reaction if consumed by an individual with an allergy or severe sensitivity. Tate's Wholesale, Llc.
Devices AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold separately for the Staphylococcus QuickFISH BC test Catalog number: QFFixBC1-50 (a component for QFSTABC1-50) Lot Number: 04914 Exp. Date: 2015-06 Class II Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC Advandx Inc
Drugs Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. Lot #: a) AGL0098B, AGL0099B, AGL0100B, AGL0101B, Exp 09/14; AGM0073B, AGM0074B, Exp 04/15; AGM0125B, AGM0126B, Exp 07/15; AGM0158B, Exp 09/15; b) AGL0092A, AGL0093A, AGL0094A, AGL0095A, AGL0096A, AGL0097A, AGL0102A, AGL0103A, AGL0104A, AGL0105A, Exp 09/14; AGM0067A, AGM0068A, AGM0069A, Exp 03/15; AGM0070A, AGM0071A, AGM0072A, AGM0085A, AGM0086A, Exp 04/15; AGM0127A, AGM0128A, AGM0129A, AGM0130A, AGM0131A,  ...
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Class II CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices. Caraco Pharmaceutical Laboratories, Ltd.
Drugs Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. Lot #: a) AGL0058B, AGL0059B, AGL0060B, AGL0061B, Exp 06/14; AGL0062B, AGL0063B, AGL0064B, Exp 07/14; AGL0083B, AGL0084B, AGL0085B, AGL0086B, AGL0087B, AGL0088B, AGL0089B, AGL0090B, Exp 08/14; AGL0120B, AGL0121B, AGL0122B, AGL0123B, Exp 11/14; AGM0001B, AGM0002B, AGM0003B, AGM0004B, Exp 12/14; AGM0021B, AGM0022B, AGM0023B, AGM0024B, Exp 01/15; AGM0031B, AGM0032B, AGM0033B, AGM0034B, Exp 02/15; AGM0053B, AGM0054B,  ...
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Class II CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices. Caraco Pharmaceutical Laboratories, Ltd.
Devices VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID). Serial Numbers J36000101 - J36000806 (J Numbers are analogous to Serial Numbers and for VITROS 3600 systems the J Numbers start with 3600XXXX) Class II Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number. Ortho-Clinical Diagnostics
Devices VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.) The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID). Serial Numbers J46000108 - J46000440 (J Numbers are analogous to Serial Numbers, for VITROS 4600 systems the J Numbers start with 4600XXXX) Class II Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number. Ortho-Clinical Diagnostics
Devices VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. The VITROS Software is a part of the VITROS 3600, 4600, & 5600 Systems. The VITROS 3600, 4600, & 5600 Systems share the same software base. VITROS Sample Programming consists of Sample Identification (SID), test requests, and patient demographics. Patient demographics include patient name, address, date of birth, gender, physician, and patient identification (PID). Serial Numbers J56000110 - J56001954 (J Numbers are analogous to Serial Numbers, for VITROS 5600 systems the J Numbers start with 5600XXXX) Class II Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and below. Internal testing confirmed that under very specific conditions, incorrect patient demographics were associated with a sample identification (ID) number. Ortho-Clinical Diagnostics
Devices Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech. Part #'s: 5450-850-000, 5450-851-000, 5450-852-000, UST-2001; Serial #'s: 01H0001 04G0251 06C0499 07G0748 08L1000 1018200054 1106200054 1202400194 1231200284 1320000054 01H0002 04G0252 06C0500 07G0749 08L1001 1018200064 1106200074 1202400204 1231200294 1320000064 01H0003 04G0253 06C0501 07G0750 08L1002 1018200074 1106200084 1202400214 1231200304 1320000074 01H0004 04G0254 06C0502 07G0751 08L1003 1018200084 1106700014 1202400224 1231200314 1320000084 01H0005 04G0255  ...
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Class II The firm received complaints regarding insufficient irrigation to the tip of the Sonopet system. Lack of irrigation can potentially lead to excessive heat at the tip. Stryker Instruments Div. of Stryker Corporation
Drugs buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 500-count bottle, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA, LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, NDC 64679-101-07. Lot #: DN10635, Exp 01/15; DM13402, DN10247, Exp 11/14; and DM13449, Exp 07/14 Class III Failed Impurities/Degradation Products: Out of specification levels of the impurity m-chlorobenzoic acid were observed. Wockhardt Usa Inc.
Drugs Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby Operations, Ontario, Canada L1N 5Z5; Distributed by: Novartis Pharmaceuticals Corp., East Hanover, New Jersey 07936; NDC 0078-0436-05, UPC 3 0078-0436-05 2. Lot # PKTS, Exp 01/17 Class III Failed Tablet/Capsule Specifications: Ink identification had rubbed off tablets in transit making them illegible to pharmacists and consumers. Novartis Pharmaceuticals Corp.
Food MuscleTech Amino Build, Fruit Punch flavored, Net Wt. 0.58 lbs (261g) UPC 31646-70392 and Net Wt. 0.96 lbs (435g) UPC 31656-70479 Lot 403720 and 403721 Class II Milk Specialties Global is recalling 2 lots of MuscleTech Amino Build Fruit Punch due to potential cross contamination with egg protein. Milk Specialties Co
Devices Tapered-Screw Vent Implant, HA, 4.7mmD x 8mmL x 4.5mm, Part No. TSVWH8. dental implant component. Lot No. 62552804 Class II Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm." Zimmer, Inc.
Devices Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the Silex Sacroiliac Fusion System. The soft tissue shields are surgical instrument guides in the Silex Sacroiliac Joint Fusion System for spinal surgery. Part numbers X079-0096 and X079-0097 with Lot #12320 Class II Revision B of the tissue shields of the device was 7 mm longer than the previous design. X Spine Systems Inc
Biologics Red Blood Cells Leukocytes Reduced Irradiated W290613048934; Class II Blood products, collected in a manner where the sterility of the products may have been compromised, were distributed. Penrose-St Francis Health Services Blood Bank
Biologics Fresh Frozen Plasma W290614052314; W290614051423; W290614051402; W290614051405; W290614051407; W290614051408; W290614051426; W290614051214; W290614050926; W290614050895; W290614050820; W290613048777; W290613048784; W290613048780; W290613048785; W290613048827; W290613047881; W290613047883; W290613047887; W290613047895; W290613047896; W290614051640; W290613048356; W290613048015; W290613048032; W290613048563; W290613048564; W290613048201; W290613048234; W290613048259; W290613048273; W290613047897; W290614050746; W290613048010; W290613047864; W290613047571; W290613049006; W290613049003; W290613048886; W290613048585; W290613048599; W290613048632; W290613048663; W290613048460; W290613048546; W290613048548; W290613048549; W290613048550; W290613048555; W290613048556;  ...
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Class II Blood products, collected in a manner where the sterility of the products may have been compromised, were distributed Penrose-St Francis Health Services Blood Bank
Biologics Red Blood Cells Leukocytes Reduced W290613049083; W290613049031; W290613048853; W290614052529; W290614052569; W290614052868; W290614052874; W290614052881; W290614051857; W290614051663; W290614051358; W290614051360; W290614050797; W290614050785; W290613048505; W290613048086; W290613048088; W290613047668; W290613047671; W290613048852; W290614050579; W290613048854; Class II Blood products, collected in a manner where the sterility of the products may have been compromised, were distributed Penrose-St Francis Health Services Blood Bank
Drugs Tetrahydrozoline HCL, 16 kg drum. Societa Italiana Medicinali Scandicci (S.I.M.S.), Made in Italy. NDC 12660-0048 CAS #522-48-5 Lot: 168.862, Expiry: 6/2017 Class II CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy. SST Corporation
Food Allegro Original Marinade, 12.7 fl oz (375 mL), UPC 0 74964 00100 7 Best By 6/17/17, Lot 14168 Class III Elevated yeast level with likelihood of premature spoilage. Allegro Fine Foods Inc
Biologics Cornea PH121898OS; CH121898OD; Class III Human corneas, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed. Saving Sight
Drugs Alprazolam Tablets, USP 0.25 mg, UD 100 Tablets (10 x 10), Rx Only, Mfg By: Sandoz, Inc., Princeton, NJ 08540 --- NDC 63739-644-10 Lot 102492, exp 01/2016 Class II Presence of Foreign Substance; tablets may contain stainless steel metal particulates Mckesson Packaging Services
Drugs Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. Mfg. for HLI, Portland, OR 97222 NDC: 19392-120-03. Labeled A) Anne Arundel County Mental Health Agency, Inc., B) Family Advocacy Program, and C) Henderson Community College Nursing. Lot #: MB140417; Expiry: 04/2017. Class II Microbial Contamination of Non-Sterile Product HLI dba Humphreyline Inc
Devices Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal. Lot No. 2886730 Class II ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ICU Medical, Inc.
Devices Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodrip, Item No. 011-46104-33 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal. Lot No. 2873662 Class II ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ICU Medical, Inc.
Devices Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal. Lot No. 2841944, 2841945, 2859326, 2865873, 2869445 Class II ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ICU Medical, Inc.
Devices Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46106-22 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal. Lot No. 2848741, 2859329, 2862831, 2869453 Class II ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ICU Medical, Inc.
Devices Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal. Lot No. 2866991 Class II ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ICU Medical, Inc.
Devices Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal. Lot No. 2841690, 2841691, 2859331 Class II ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ICU Medical, Inc.
Devices Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal. Lot No. 2866974 Class II ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ICU Medical, Inc.
Devices Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal Lot No. 2817530, 2852405, 2869455, 2883663 Class II ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ICU Medical, Inc.
Devices Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal. Lot No. 2837897 Class II ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak. ICU Medical, Inc.
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