Blood products, in which quality control and distribution of products  did not meet specifications, were distributed.
El Tampiqueno Original Queso Fresco White Soft Cheese, Manufactured and distributed by El Tampiqueno Cheese Products, 1210 Summit St. Schulenberg, Texas 78956
The product has the potential to be contaminated with Salmonella.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
US: Nationwide (IL, IN, KS, KY, MO, NM, OK, TX)
40 lb poly-paper bags of poultry feed labeled in part: Nutrena; Nature Wise; Meatbird; 22% Crumbles; Minneapolis, MN 55440; www.NutrenaNatureWise.com.
Cargill Animal Nutrition is conducting a recall of Nutrena Naturewise Meatbird feeds in 40 bags due to incorrect levels of calcium.
40 and 50 lb poly-paper bags of poultry feed labeled in part: Nutrena; Nature Wise; Chick Starter Grower; 18% Crumbles; Minneapolis, MN 55440; www.NutrenaNatureWise.com.
Cargill Animal Nutrition is conducting a recall of Nutrena Nature Wise Chick Starter Grower feeds in 40 and 50 lb bags due to incorrect levels of calcium.
Mut Dua Non YOUNG COCONUT CANDY, Net Weight: 10.6oz (300g), UPC 8 935054 702377 -- Product of Vietnam -- Packed for: HONG LEE TRADING INC. 225 JOHNSON AVE BROOKLYN, NEW YORK 11206 (718) 386-2100 --- NUTRITION FACTS: Serving Size 30oz. (85g), Servings per container 6
UPC code 8935054702377 and no other coding
The product was found to contain undeclared sulfites (258.6 ppm) plus undeclared colors Yellow #5, Blue #1 and Red #3 based on sampling and analysis by New York State Department of Agriculture & Markets.
H-E-B Chipotle Con Queso; HOT; with Real Chipotle Peppers; NET WT; 16 OZ (1 LB) 454g; Made with Pride and Care for H-E-B, SAN ANTONIO, TEXAS 78204.  Distributed in cases of 12/16 oz. jars.
Undeclared Wheat due to a supplier's inadvertent use of a wheat product instead of whey in preparing the cheese premix for the recalling firm.
HILL COUNTRY FARE; Salsa Con QUESO Sauce; Medium - PICANTE; NET WT 16 OZ (1LB) CONT. NET. 454g;  DISTRIBUTED BY: H-E-B, SAN ANTONIO, TX 78294.  distributed in cases of 12/16 oz. jars
Roundy's Salsa Con Queso; NET WT; 16 OZ (1 LB) 454g; DISTRIBUTED BY  Roundy's Milwakee, WI 53202.  Distributed in cases of 12/16 W jars.
HY-TOP FRENCH ONION DIP; NET WT 9 OZ. (255g); DISTRIBUTED BY FEDERATED GROUP, INC.; ARLINGTON HEIGHTS IL. 60005-1096.  Shipped in cases of 12/9 oz containers.
Laura Lynn French Onion; DIP; NET WT 9 OZ (255g); DISTRIBUTED BY INGLES MARKETS, INC.; ASHEVILLE, NC 28816.  Shipped in cases of 12.
YF brand CRACKER (SESAME), Net Wt. 14 oz. (400g), UPC 6 920580 733416 --- The product is packed in a plastic package.
The product was found to contain undeclared peanuts based on sampling and analysis by New York State Department of Agriculture & Markets.
GONG XIFACAI GIFT CHOCOLATES, 238 grams, UPC 6 934169 900335 --- MANUFACTURER: JIANGXI GOLDEN EAGLE FOOD CO. LTD, ADD: NO. 188, YONGQIANG ROAD (NORTH), WANGCHENG TOWN, XINJIAN COUNTY, JIANGXI, CHINA 330100 --- The product is packed in a plastic tray with a plastic overwrap package.
The product contained undeclared peanuts and milk based on sampling and analysis by New York State Department of Agriculture & Markets.
Fresh Atlantic Salmon.   No finished packaging. Fresh Salmon is placed in white styrofoam box and delivered to area restaurants.
No codes. Production date from 05/27/14 to 05/28/2014.
Firm is initiating a voluntary recall of Fresh Farmed Atlantic Salmon and Fresh Wild Tuna because it has the potential to be contaminated with Listeria monocytogenes. Firm was notified that FDA environmental swab samples had a positive result for Listeria monocytogenes.
Fresh Wild Tuna.   No finished packaging. Fresh Tuna is placed in white styrofoam box and delivered to area restaurants.
Grace Classic Coconut Milk Net 13.5 FL OZ (US) (400 mL) PRODUCT OF THAILAND Packed for: GraceKennedy Limited, 73 Harbour Street Kingston, Jamaica, W.I.
Label misprint on the front panel. Incorrectly declaring ''No Gums, Thickeners or Stabilizers Added''
Blood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed.
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Blood products, collected from donors who emigrated from a malarial endemic area, were distributed.
Blood products, possibly air contaminated but not  labeled with a 24-hour expiration date, were distributed.
Worldwide Distribution -- USA, in the states of CA, TX, IL, MI, MS, ID, NY, FL, MD, PA, OR, GA, CO, WA, NJ, HI, and NC, including DC; and the countries of the countries of Spain, England, Holland, and United Kingdom.
CooperSurgical H/S CATHETER (PART # 61-5007)   Intended for Hysterosonography/ Hysterosalpingography.
Siemens Luminos dRF, Ysio or Uroskop Omnia systems.   The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
model numbers 10094200, 10281163, 10281013, 10094910 with multiple serial numbers
It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunction can result in longer radiation exposure than required. This may also result in an overexposed image that is not of diagnostic quality. As a result the taken examination needs to be repeated.  This malfunction can only occur in automatic exposure mode. Moreover using this mode the malfunction will statistically only occur approximately once every 7000 images.
Worldwide Distribution -- USA, including the states of TX, OH, PA, KS, FL, NV, IL, WA, MN, NJ, NC, UT, NY, CA, MD, CO. NE VA, and AZ; and, the country of Canada.
Prime Care  Transcend Mattress, Prime Care  Transcend Perimeter Mattress, Prime Care  Transcend Advanced Mattress, Prime Care  Transcend Advanced Perimeter Mattress, Prime Plus  Bariatric Mattress and Prime Plus  Bariatric Perimeter Mattress, individual units packaged seperately.     Model Numbers: TCM3576, TCM3580, TCM3580P, TCM3584, TCM4280, TCM4280P, TCM4284, TACM3576, TACM3580, TACM3580P, TACM3584, PPBM396, PPBM426, PPBM426P, PPBM486, PPBM546, PPBM397, PPBM427, and PPBM487.    Intended to protect inner foam layers of mattress from any fluids that may be on the mattress.
The firm found that the top cover of the mattresses were delaminating.
Whole Foods Market Chocolate Chewies Cookies in  clamshell packaging, sold by the lb.  Item # 6126
AB SCIEX API 3200MD'' LC/MS/MS System with software:  MultiQuantMD  3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens  Part Number 5024543.
Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with MultiQuantMD 3.0 software may provide incorrect data for patient diagnosis
***Baxter***Buretrol Solution Set***105'' (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male Luer Lock Adapter with***Retractable Collar***Fluid path is Sterile, Nonpyrogenic***Indications for Use: For the administration of fluids from a container into the patient's vascular system through a vascular access device.***
Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the drip chamber.  Affected product codes are:  2C7564, 2C8864 and 2H8864.
***Baxter***BURETROL Solution Set***105'' (2.7 m) 150 mL Burette***Drip Chamber Filter Valve***3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic.  ****Indications for Use: For the administration of fluids  from a container into the patient's vascular system  through a vascular access device.***
***Baxter***Non-DEHP***BURETROL Solution Set 105'' (2.7 m), 150 mL Burette***Drip Chamber Filter Valve  3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic.***Indications for Use: For the administration of fluids from a container into the patient's vascular system through a vascular access device.***
2H8864- Non-DEHP Buretrol Solution Set, 150 mL CLEARLINK Burette, lots: DR13E10011  DR13E10029  DR13E11019  DR14A13013  DR14C08043
Central Texas Regional Blood & Tissue Center
Blood products, in which labels applied to blood units or products were incorrect or missing information, were distributed.
US:  CA, CO, FL, GA, IN, KY, LA, MD,MI, NY,NC,OH, PA, SC, TN, TX, VA,WI.   OUS: UNITED KINGDOM, TURKEY, THAILAND, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SINGAPORE, SAUDI ARABIA, PHILIPPINES, PANAMA, PAKISTAN, NORWAY, NICARAGUA, NEW ZEALAND, NETHERLANDS, MEXICO, LEBANON, KUWAIT, REPUBLIC OF KOREA, JAPAN, ITALY, INDONESIA, INDIA, GERMANY, FRANCE, FINLAND, EGYPT, CZECH REPUBLIC, COLOMBIA, CHILE, BULGARIA, BELGIUM, AZERBAIJAN, AUSTRALIA.
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service exchange units.   The affected modules could be in use with any of the following GE host devices:  -CARESCAPE respiratory modules with CARESCAPE Monitors B850, B650 and B450, S/5 modular monitors, Avance CS2 and Aisys CS2 Anesthesia Carestations, B40 Patient Monitor  -Airway Gas Option N-CAiO modules with B40 Patient Monitor
GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules, the Airway Gas Option and their respective service exchange units.
Worldwide Distribution - USA including OR, AZ, TN, MA, MD, GA, FL, NY, IA, IN, TX, MI, PA, UT, CA, MN, MO, OH, KS, OK, MT, FL, AL, CO, TN, and WI and Internationally to Australia.
Stryker Aria Implant Inserter, REF 48758500,     This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights, and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation, ergonomically shaped anterior edges, and flat posterior edges. This device does not sustain or support life.
Stryker has initiated the recall of its Aria Standard and Specialty Implant Inserters due to complaints of product fracturing.
Specialty Aria Inserter, REF IS3021ARI, Non-Sterile,     This instrument is part of the Aria product brand. It is used for Implant insertion into the disc space. The Aria Inserter PEEK Spacer System offers implants that are interbody fusion devices intended for use as an aid in spinal fixation. These hollow implants are offered in a variety of lengths, heights, and lordotic angles designed to adapt to different patient anatomies. They have serrations on the superior and inferior surfaces designed for multidirectional fixation, ergonomically shaped anterior edges, and flat posterior edges. This device does not sustain or support life.
BIOMET 3i Certain Bellatek Encode Healing Abutment    Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
Model Number IEHA458, Lot number: 1167545.
Identifiers on the label are correct but the label has the incorrect color coding.
Blood products, collected from a donor considered to be at increased risk for Creutzfeldt-Jacob Disease (CJD), were distributed.
Blood products, collected from a donor considered to be at increased risk for Creutzfeldt-Jacob Disease (CJD), were distributed
Blood product, collected from a donor who received a tattoo within 12 months of donation, was distributed.
American Red Cross Blood Services Heart of America Region
Platelet products, collected on an instrument which failed leukoreduction quality control procedures, were distributed.
Blood product, collected from a donor who did not have a complete physical examination, was distributed.
US only to one repacker/relabeler and three medical facilities. The relabeler was identified as: KLS Martin, 11201 St. Johns Industrial Parkway S, Jacksonville, FL 32246 (904) 641-7746
Integra Container Lid,  Size, Red; Container Lid,  Size, Blue; Container Lid,  Size, Red; Container Lid,  Size, Gold; Container Lid,  Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red  Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622    The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid.
Container Lid,  Size, Red; Container Lid,  Size, Blue; Container Lid,  Size, Red; Container Lid,  Size, Gold; Container Lid,  Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red  Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622
Integra LifeSciences has identified through an internal investigation that some colored lids for Integra container systems were not yet cleared by the FDA for sale and were inadvertently distributed.
Worldwide Distribution - US (nationwide) and the countries of: France, Germany, Italy, Norway, UK and United Arab Emirates.
Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform.   Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.
A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended
Marjon Alfalfa Sprouts, Pre-Washed Ready to Eat: Keep Refrigerated. NET WT. 6/4 oz. packaged in cups and bags; Marjon Specialty Foods, Inc. 3508 Sydney Rd., Plant City, FL 33567 Grown and Packed in the USA. UPC 20077554000231. Used by 7/06/14.
Firm environmental samples found Listeria in the sprout production area.
Marjon Bean Sprouts, Keep Fresh Zip Lock: Keep Refrigerated. NET WT. 8/8 oz. plastic bag; 5 lb bag and 2/5 Bags; Marjon Specialty Foods, Inc. 3508 Sydney Rd., Plant City, FL 33567 Grown and Packed in the USA. UPC codes: 10077554000012; 0200077554000466; 010077554000463 Used by 06/28/14.
Marjon Kale Sprouts, Keep Refrigerated. NET WT. 6/3 oz. packaged in cups; Marjon Specialty Foods, Inc. 3508 Sydney Rd., Plant City, FL 33567 Grown and Packed in the USA. UPC 20077554000231. Used by 7/06/14.
Marjon Spicy Sprouts, NET WT. 6/6 oz. packaged in bags; Marjon Specialty Foods, Inc. 3508 Sydney Rd., Plant City, FL 33567 Grown and Packed in the USA. UPC 010077554000197. Used by 7/06/14.
Worldwide Distribution - US (nationwide) in the states of AZ, CA, MO, MS, TX and UT. and the countries of:  Austrialia, Austria, France, UK, Italy, Japan, Spain, India, and the Netherlands.
RADIANCE v. 2.4X, 2.5X and 2.6X   Product Usage:  RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.
US Distribution including the states of : CA, FL, HI, IL, IN, MD, MI, MN, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA and WI.
The BD MAX'' MRSA Assay, catalogue #442953.   An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.
All Lots with the expiration date January 21, 2014 or later
The performance of the assay no longer conforms to the following statement in the Analytical Specificity section of the Package Insert:   One hundred-eleven (111) out of 111 MSSA strains tested at extremely high concentrations (> 106 CFU/swab), produced negative results with the BD MAXTM MRSA Assay.    Based on our investigation of incorrect results observed when testing the College of American Pathologists (CAP) surveys MRS5-A 2014 and MRS5-B 2014 using the BD-MAX MRSA Assay, it was confirmed that one of the samples for each of these surveys yielded false positive results. This investigation currently continues to determine the root cause and identify appropriate corrective measures.
Walter L. Shepeard Community Blood Center, Inc.
Blood product, in which donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked, was distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood product, manufactured without additive solution, was distributed.
Blood products, in which donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked, were distributed
Nationwide Distribution including TX, CA, IL, and FL.
Streamline MIS Spinal Fixation System Fixed Rod Holder  NON STERILE, Rx only   The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion. The device is indicated for all the following indications: degenerative disc disease (ODD) (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, kyphosis, and /or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Streamline MIS instrumentation, when used with the Streamline MIS Spinal Fixation System, is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The affected fixed rod holders did not allow the instrument to lock down on the spinal rod.
Blood product, collected from a donor who gave history which warranted deferral or follow up and was not deferred or follow up questions was not asked, was distributed.
Nationwide Distribution in the states of AZ, FL, MD, NV, OK, PA, and TX.
Life Force Chamber    Product Usage:The product is intended for restful contemplation and spirituality.
The Life Force chamber is marketed and promoted as a medical device, intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.  Life Force of Tampa does not have an approved application for premarket approval in effect, or an approved application for an investigational device exemptions and has not notify FDA of its intent to introduce the chamber into commercial distribution as a medical device.
Worldwide Distribution - USA (Nationwide) and Internationally to Canada Australia, Great Britain, Germany, Spain, Netherlands, France.
CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE   Orthopedic
Plates manufactured from an incorrect raw material.
CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH  3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE   Orthopedic
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE   Orthopedic
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE   Orthopedic
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON STERILE   Orthopedic
CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE   Orthopedic
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EACH, Rx ONLY, NON STERILE   Orthopedic
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY, NON STERILE   Orthopedic
CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm, REF 40242025, 1 EACH, Rx ONLY, NON STERILE   Orthopedic
US Distribution to states of: CT, GA, MD, and PA.   .
DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile.   When left in place for five (5) minutes DualCap Solo'' disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.
Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile.
CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005.
Marketed without an Approved NDA/ANDA; Product contains unapproved hHCG.
Medtronic Cardiovascular Surgery-the Heart Valve Division
Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012.   Used use in conjunction with Hancock Conduit Model 105  to provide an alternate method for relief of left ventricular hypertension.
Medtronic has decided to discontinue production and distribution of this low-volume product.
Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY; and countries of: Armenia, Belgium, Germany, Denmark, Finland, France, UK, Italy, Japan, South Korea, Netherlands, Norway, Russia, Sweden, Singapore, Taiwan, Tanzania, and South Africa.
PROXIMATE Skin Stapler.  Product is in a sterile barrier system.  The barrier is a flexible blister packaging made from Amcor C-film.  Lid made with Tyvek coating with Perfecseal heat seal coating.     Skin stapler is a sterile instrument for use in a single patient, which is designated to apply rectangular stainless stell staples for routine wound closure.
PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35) Batch  L4EG3F  L4EK3Y  L4EP22  L4ER1D  L4ER9X  L4EU87    PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35)  Batch   L4EG2T  L4EH20  L4EH85  L4EK50  L4EN58  L4EN94  L4EP2F  L4EP6G  L4ER1L  L4EU0J  L4EV07    Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117)  Batch   L91J4U  L91K38  L91K6N  L91M8N  L91N22  L91W33  L91X5V    Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK 158) Batch   L90W40  L90X3C  L90Y0U  L90Y4V  L90Z7C  L9108Z  L91151  L91223  L91970  L91A7N  L91C5C  L91E2Z  L91E6P  L91G46  L91J4L  L91K3A  L91M4U  L91T81
US Distribution including the states of  PA, CA, TX, NM, and OH.
Merci Retriever   Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date.
0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-0049-03
Lack of Assurance of Sterility; complaints of mold in the overpouch