Worldwide Distribution: US (nationwide) including states of: NJ and IL; and Internationally to: Finland, Japan, and Germany.
1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface.    2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK  surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea.     3) The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that may enclose a volume of the cornea.
Serial Numbers: FLM4135, FLM3281, FLM2963, FLM3907, FLM3817
A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could potentially cause the video monitor to shut off.
Nationwide Distribution: US including Puerto Rico.
Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in cartridges of 50 discs, 5 cartridges/pack. 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 to assist in the determination of a suitable antibiotic agent for treatment purposes
Cartridges may contain individual discs which were not impregnated with antibiotic.
Distribution was nationwide, as well as to Puerto Rico.  There was also military distribution, but no foreign distribution.
Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in cartridges of 50 discs, 5 cartridges/pack. 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 to assist in the determination of a suitable antibiotic agent for treatment purposes.
Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in cartridges of 50 discs, 5 cartridges/pack. 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 to assist in the determination of a suitable antibiotic agent for treatment purposes
Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in cartridges of 50 discs, 5 cartridges/pack. 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 to assist in the determination of a suitable antibiotic agent for treatment purposes.
Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Apple Cinnamon flavor, 6-count packets per carton,  Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ  07054-0622, NDC 0067-7916-06, UPC 3 0043-0479-16 3.   Also packaged under foreign label: NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Apple Cinnamon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05205 2.
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Berry Infused with Menthol & Green Tea flavors, 6-count packets per carton, , Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ  07054-0622, NDC 0043-6257-06, UPC 3 0043-6257-06 2.   Also packaged under foreign label: NeoCitran Extra Strength Daytime Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, dextromethorphan hydrobromide 20 mg) powder packets, Invigorating Berry with Green Tea flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada Inc., Mississauga, ON, UPC 0 58478 10366 2.
Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol & Green Tea flavors and Nighttime formula (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, and phenylephrine hydrochloride 10 mg), Honey Lemon Infused with Chamomile & White Tea flavors; packaged in a) 24-count packets per carton containing 6-count Daytime and 18-count Nighttime packets (UPC 3 0043-6403-24 7); b) 12-count packets per carton containing 6-count Daytime and 6-count Nighttime packets (UPC 3 0043-6403-12 4); Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.
Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ  07054-0622, labeled as a) Theraflu Sinus & Cold (NDC 0067-6319-06, UPC 3 0043-6319-06 7) and b) Theraflu Cold & Sore Throat (NDC 0067-6716-06, UPC 3 0043-0467-16 0).   Also packaged under foreign labels: NeoCitran Cold & Flu powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05009 6; and Theraflu Exthegran powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812904) and b) 10-count packets per carton (UPC 7 501124 814588), Distributed by Novartis Farmaceutica S.A. De C.V., Mexico
Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Green Tea & Honey Lemon flavors, packaged in a) 6-count packets per carton (NDC 0067-6426-06, UPC 3 0067-6426-06 8) and b) 1-count packet per card (NDC 0067-6426-01, UPC 3 0067-6426-01 3), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ  07054-0622.
Theraflu MAX-D Severe  Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60 mg) powder packets, Natural Citrus flavor, 6-count packets per carton,  Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ  07054-0622, NDC 0067-6427-06, UPC 3 0067-6427-06 5.   Also packaged under foreign label: NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief powder packets, Soothing Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 10701 1.
Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ  07054-0622, NDC 0067-6318-06, UPC 3 0043-6318-06 0.
Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ  07054-0622, NDC 0043-0483-06, UPC 3 0043-0483-06 1.
Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon Infused with Chamomille & White Tea flavors, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ  07054-0622, NDC 0043-6256-06, UPC 3 0043-6256-06.   Also packaged under foreign label: NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, diphenhydramine hydrochloride 25 mg, Soothing Honey Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., UPC 0 58478 10594 9.
NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 20mg, chlorpheniramine maleate 4 mg, ascorbic acid 5 mg) powder packets, Soothing Lemon flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada Inc., Mississauga, ON, labeled as a) NeoCitran Extra Strength Nighttime Total 7 Symptom Relief (UPC 0 58478 10063 0) and b) NeoCitran Extra Strength Cough, Cold & Flu (UPC 0 58478 47363 5).
NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg) powder packets, Natural Source Cherry flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, labeled as a) NeoCitran Ultra Strength Total Flu 7 Symptom Relief (UPC 0 58478 47365 9) and b) NeoCitran Extra Strength Sore Throat & Cough (UPC 0 58478 47365 9).
NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga , ON, UPC 0 58478 05103 1.   Also packaged under foreign labels:   Theraflu Extra Cold and Flu powder packets, Lemon flavor, 10-count packets per box, UPC 4 607045 191395 (Russia and Former Soviet Union product); Theraflu Nighttime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, UPC 8 806536 013925 (Korea product);
NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05503 9.
NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05703 3.   Also packaged under foreign label: Theraflu Daytime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7116-06, UPC 8 806536 01402 1 (Korea Product)
Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812881) and b) 10-count packets per carton (UPC 7 501124 814595), Distributed by Novartis Farmaceutica, S.A., DE C.V., Mexico.
Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berries flavor, 10-count packets per box, UPC 4 607045 191760. (Russian product and Former Soviet Union product)
Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA
Presence of Particulate Matter; Glass particulates observed in vials
Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, and Puerto Rico; and Internationally to: Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.
Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Chemistry Products COCM Reagent due to inaccurate quality control results.
Worldwide Distribution:  US (nationwide) including Puerto Rico; and internationally to: Costa Rica and Russia.
TRUFILL n-Butyl Cyanoacrylate  (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code:  631-400;     The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired.
TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System:  One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500      The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery.
Worldwide Distribution - USA Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. Foreign distribution was made to Brazil, Canada, Chile, Czech Republic, France, Germany, Iraq, Israel, Italy, Japan, Malaysia, Saudi Arabia, Slovenia, South Korea, Spain, Turkey, and United Arab Emirates.
Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box.    Product Usage:  This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.
Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.
Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box.    Product Usage:  This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region.
Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only.  Mfd by: Fresenius Kabi USA, LLC   Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA; for Nexus Pharmaceuticals Inc; Vernon Hills, IL 60061.  NDC 14789-500-10.
Presence of particulate matter consistent with delamination of the glass vial container.
sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Distributed by: Greenstone LLC, Peapack, NJ 07977 -- MADE IN INDIA --- NDC 59762-4960-1
Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36 month shelf life, instead of the 24 month shelf life
Blood products, with a low platelet counts, were distributed.
Blood Product, which did not meet specifications, were distributed.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Blood Products, in which component preparation/component were not prepared in accordance with specifications, were distributed.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Worldwide Distribution: US (nationwide) and Internationally to: Eschbach, Germany and Europe.
Zimmer Segmental Systems; Polyethylene Inserts, Size B.   Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty.
After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert.
Zimmer Segmental Systems; Polyethylene Inserts, Size C.   Knee replacement.
Worldwide Distribution - USA including  AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey & United Kingdom.
ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark   A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.
Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA.  NDC: 0093-5414-95.
Failed stability testing; this product is below specification for preservative content.
US Distribution including the states of NY, IN, UT, MN, OH, MA, SD, CA, NJ, and PA.
BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique  Quebec, Qc, Canada, G1P 4S5***     The BD GeneOhm'' Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD.
An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples.
Heavenly Blue, (Raw milk, salt, culture, coagulant ), Flat Creek Lodge,  367 Bishop Chapel Church Rd, Swainsboro, GA 30401. The raw milk blue cheese is packaged in clear plastic, with sizes ranging from 1/2 lb to whole wheels.
Product was found to be contaminated with Salmonella.
Worldwide Distribution - US (nationwide) and Internationally to: Belgium and Canada.
MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880.   Product Usage:  The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted Port Kits These products are used for patient therapies requiring repeated access to the vascular system. They are indicated for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. Subject ports are not indicated to Power Injection. Port access is performed by percutaneous needle insertion using a non-coring needle. The system consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque silicone catheter.
Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device.
Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Catheter. Product Code 0602180   Usage:  The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted Port Kits These products are used for patient therapies requiring repeated access to the vascular system. They are indicated for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. Subject ports are not indicated to Power Injection. Port access is performed by percutaneous needle insertion using a non-coring needle. The system consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque silicone catheter.
Worldwide Distribution: US (nationwide) and Internationally to: Canada.
Medrad Veris MR Monitor units    The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas monitoring, system alarms, and patient analysis will be available to the care provider from the monitor.
The main board, P/N 301641, installed in some Medrad Veris MR Monitor units may be faulty and could lead to unexpected shutdown of the system while in use, resulting in the loss of vital signs information from the monitor.
Blood product, collected from a donor who may have traveled to a malarial endemic area, was distributed.
Blood products, collected from a donor who may have traveled to a malarial endemic area, were distributed.
ORCHESTRA/ORCHESTRA PLUS Programmer implanted with the following pacemaker models. - REPLY Models D, DR, VDR, SR  - ESPRIT Models D, DR, S, SR  - FACIL Model DR1
Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemaker.
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, which did not meet the acceptable product specifications, were distributed.
Southern California Permanente Medical Group
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood product, which did not meet the acceptable product specifications, was distributed.
Worldwide Distribution: US (nationwide) and the country of Canada.
Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems.   Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine.
ADVIA 1200 with software versions: V2.00 and V2.01   ADVIA 1650 with software versions V3.52 and V4.01
An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result.
American Natl Red Cross Mid Atlantic Region
Blood products, collected from a donor who may be at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Worldwide Distribution: US (nationwide) including states of: CA, CO, FL, GA, IL,IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI; and internationally to: Australia Belgium, Canada, China, Finland, France, Germany, Hong Kong, Italy, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates,  and United Kingdom.
DRX-Evolution with FF WS   These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
675 units Total (145 units domestically & 530 units internationally)
Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement.
DRX-Evolution with CSH WS   These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
840 units Total (181 units domestically & 659 units internationally)
DR 7500 with FF WS   These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
493 units Total (107 units domestically & 386 units internationally)
Worldwide Distribution - USA (nationwide) and Canada.
Dimension Vista Cyclosporine Flex reagent cartridge   an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant patients.
Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges.
Worldwide Distribution - US Distribution including the states of IL, IN, LA, NJ, TX, WA and WI., and the countries of Belgium, Germany, Italy and Netherlands.
XiO RTP System   The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
Model or Catalog No. MUJ; Software Version XiO Versions 4.80 and higher
When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan.
Worldwide Distribution: US (nationwide) including DC and PR except SD, VT and WY; and Internationally to: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, EGYPT, GERMANY, UNITED KINGDOM,M, IRELAND, IRAQ, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MARITIUS, MALDOVA, NEW ZEALAND, NIGERIA, PAKISTAN, PANAMA, PARAGUAY, PERU, POLAND, QATAR, RUSSIA, SLOVAKIA, SOUTH AFRICA, SWEDEN, SWITZERLAND, TUNISIA, UNITED ARAB EMIRATE, VENEZUELA, CHILE, CANADA, BERMUDA.
GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients.  K073462: The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, inoninvasive blood pressure, heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operators manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs. K992929: The Dash 3000 Patient Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and m
GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance.
Nationwide Distribution (all states in continental USA including DC and PR except SD,  VT and WY.   OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, EGYPT, GERMANY, UNITED KINGDOM,M, IRELAND,  IRAQ, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, KUWAIT, LEBANON, LITHUANIA, MARITIUS, MALDOVA, NEW ZEALAND, NIGERIA, PAKISTAN, PANAMA, PARAGUAY, PERU, POLAND, QATAR, RUSSIA, SLOVAKIA, SOUTH AFRICA, SWEDEN, SWITZERLAND, TUNISIA, UNITED ARAB EMIRATE, VENEZUELA, CHILE, CANADA, BERMUDA.
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes.  The Solar 8000i with Patient Data Module/Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic, surgical center or doctors office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general intensive care unit (ICU), critical care unit, surgical intensive care unit (SICU), respiratory intensive care unit, coronary care unit (CCU), medical intensive care unit (MICU), pediatric intensive care unit (PICU), or neonatal intensive care unit (NICU). The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output nad respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from
GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another.  K900540: TRAM modules are intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of TRAM modules is to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. The TRAM module functions as a transport monitor during transport, and in the bedside monitor during ICU or OR monitoring. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. TRAM modules acquire, process and store information regarding these parameters. TRAM modules incorporate different monitoring capabilities based on their configuration. K011000: The TRAM 2001 Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The TRAM 2001 Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric, and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM 2001 Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. The TRAM 2001 Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can b
TopCare Clifford THE BIG RED DOG power toothbrush for kids!
Ranir, LLC is recalling all lots of Up & Up brand Kid's Power Toothbrush and TopCare brand Clifford Kids Power Toothbrush because the tufted disk may become detached from the power brush handle. If the tuft retention disk detaches from the handle, it is a potential choking hazard for children three years old and younger.
Ranir, LLC is recalling all lots of UP & UP brand Kid's Power Toothbrush and TopCare brand Clifford Kids Power Toothbrush because the tufted disk may become detached from the power brush handle. If the tuft retention disk detaches from the handle, it is a potential choking hazard for children three years old and younger.
Worldwide Distribution - US (nationwide) including Washington D.C., Guam, and Puerto Rico; and Internationally to: Afghanistan, Algeria, Argentina, Australia, Austria, Azerbaijan, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina faso, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Korea (Republic of), Kuwait, Lebanon, Libyan Arab Jamahiriya, Macedonia, Malaysia, Mali, Malta, Martinique, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Niger, Norway, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yemen.
Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems:  Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII     Product Usage:  The systems are intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations on both adult and pediatric subjects. The systmes are used for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
GE has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension.  During several Preventive  Maintenance activities it was discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the carriage were missing since installation of the system.  GE is not aware of any fall of the overhead monitor suspension.
Worldwide Distribution: US (nationwide) and internationally to: Canada, Italy, P.R. China, Argentina, Pakistan, South Africa, Egypt, Iran, Vietnam, Indonesia, Brazil, Hungary, Bulgaria, India, Spain, Switzerland, Trinidad, Tobago, Italy, Algeria, Croatia, Turkey, Japan, Germany, Portugal, Poland, France, Sri Lanka, Russian Federation, France, Lebanon, Slovakia, Ukraine, Pakistan, and Korean Republic.
PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops.    Manufactured by:  SIEMENS AG, MEDICAL SOLUTIONS   Roentgenstrasse 19-21   Kemnath,  GERMANY  95478     The intended use of the SIEMENS branded, ARTISTE'', ONCOR'' and PRIMUS'' family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 TxT Treatment Table. Combined with this update instruction is a second complaint issue related to an incident in which a cable inside of the TxT''  Treatment Table has been damaged due to contacting a moving part.  The resulting short-circuit caused overheating of an electronic circuit board inside the table base.
Worldwide Distribution: US (nationwide) including states of:  AL, AR, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TN, TX, VA, VT, WA, WI & WV; and Internationally to: Austria, Belgium, Canada, Denmark, Germany, Great Britain, Italy, Netherlands, Norway, Pakistan, Russia, Singapore & South Korea.
ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems.  Distributed by Philips Medical Systems, Cleveland, OH
The recalling firm determined that visual inspections of the fork joints behind the detector that are conducted during six month preventive maintenance (PM) may not detect small cracks or deficiencies in the fork weldment.
Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.
Composix L/P with Echo PS 10'' X 13'' Product Code 0144113   The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.
Product labeling does not match product configuration.
Composix L/P with Echo PS 6'' X 8'' Product Code 0144680   The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.
Worldwide Distribution - US Inationwide) including the states of:  California, Louisiana, Massachusetts, Pennsylvania, New York, Kentucky and Michigan; and Internationally to: Bulgaria, Germany, Belarus, Russian Fed., P.R. China, India, Republic Korea, Germany, Costa Rica, Argentina, Portugal, Greece, Bulgaria, Vietnam, Hungary, Italy, Palestinian Ter, Hungary, Jordan, Egypt Poland, Greece, Curacao, St Eus, Malaysia, Egypt, Malaysia, South Africa Turkey, Thailand, Qatar and Iraq.
SIMVIEW NT and SIMVIEW NT with IDI:   October 01, 2012 Siemens ceased Simview distribution.     Manufactured by:  Mecaserto now known as Mecasim  Parc de lEsplanade  9,Rue Niels Bohr  77400 Saint Thibault des Vignes- France    The intended use of the SIEMENS branded SIMVIEW NT and SIMVIEW NT with IDI is a radiation therapy simulation system.
In a very rare occurrence an intended movement of the SimView NT simulation system components could not be stopped with usual hand control or the collision detection functionality.
Worldwide Distribution - USA (nationwide) including Puerto Rico; and Internationally to: Belgium, Canada, Chile, Mexico, Costa Rica, Kuwait, United Kingdom, Greece, Czech Republic, Latvia, Turkey, China, France, Italy, Brazil, Korea, Germany, Thailand, Egypt, Austria, Dominican Republic, India, Israel, Colombia, Japan, Netherlands, Venezula, Saudi Arabia, Argentina, Malaysia, Sweden, Rosersberg, Lebanon, South Korea, Finland, United Arab Emirate, Taiwan, Panama, Uruguay, Singapore, Hong Kong, Ecuador, Peru, Oman, Spain, Lithuania, and South Africa.
Vital Signs Anesthesia Circuits   The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to increase the airway pressure of a patient.
Vital Signs Devices (VSD), a GE Healthcare Company, has become aware through a customer complaint of a safety issue associated with a certain Breathing Circuit. A circuit in use was occluded by a blue port cap that was inadvertently attached to the circuit as a result of an internal inspection error and will cause occlusion of gas flow.
Worldwide Distribution-USA (nationwide) including the states of  AK, MD, NH, NV, OH, and OR, and the countries of Australia, China, France, India, Indonesia, Italy, Korea, Mexico, Poland, Romania, Russia, Spain, Switzerland, Taiwan, Thailand & United Arab Emirates.
Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH.   Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.
Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical Laser equals Yes, the Machine Name label and field are covered by the controls above it. The Machine Name cannot be viewed or changed.
Worldwide Distribution - Nationwide including NY, TX, NC, FL, ME, MA and MI; and Internationally to Arab Emirates, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Egypt, France, Germany, Hong Kong, India, Italy, Kosovo, Lithuania, Mexico, The Netherlands, New Zealand, Peru, Poland, Spain, and Taiwan.
Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1).   Component used to determine composition of urinary calculi, urinary sediments, bio-crystallates and diagnosis of pathological characteristics in medical applications (e.g.: testing for gout or pseudogout); also used for non-medical scientific research.
335 units Total (14 domestically & 321 internationally)
Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on Standard Pathology Microscopes due to misalignment of the lambda plate.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Pulmonary Hemi-Artery SG Used in heart surgery
Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.
Exclusively to Giant Eagle retail supermarkets in PA, OH, and MD.
Candy Place Chocolate Santas, in 11 oz  clear plastic bags, individually wrapped assortment of double chocolate, caramel, and peanut butter flavored chocolates, distributed by Giant Eagle, Pittsburgh, PA. Ingredients: Sugar, partially hydrogenated vegetable oil (Palm kernel, coconut, and/or palm), cocoa (processed with alkali) whey, lactose, skim milk, soy lecithin (emulsifier), vanillin (artificial flavor).
UPC 3003407341, Sell date:  6/24/14 Lot #:  309 (a four digit time code that changes) 27
Giant Eagle Candy Place Chocolate Santas do not declare the peanut allergen ingredient on the primary package label.  Also, the caramel variety ingredient statement was not included in the finished product label.
US Nationwide Distribution in the states of: NY, VA, IL, MO, OR, FL, DE, OH
AMS-530 7 Microbore Trifurcated Extension sets     Product Usage:  Intravascular administration set.
Defective component may cause extension sets to leak.