Recalling Firm
American National Red Cross (The), Lewis and Clark Region
Mayo Clinic Rochester Division of Transfusion Medicine

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Worldwide Distribution - US (nationwide and Puerto Rico): Units were also distributed globally to the following countries: Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Herzegovina, Bulgaria, Canada, Chile, Columbia, Costa Rica, Croatia, Curacao, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Ecuador, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hungary, India, Italy, Jamaica, Japan, Jordan, Kazakhstan, South Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Malaysia, Mexico, Mongolia, Morocco, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, Ukraine, United Kingdom, and Uzbekistan
US Nationwide Distribution in the states of KY, MD, NY, PA, VA
US Distribution to the states of : LA, AR, IA, TX, IL, MN. MS, NJ, WV, SC, LA, WY, NC and CA.
Nationwide Distribution to AZ, IL, IN, KY, NV, PA, TN, and TX
Worldwide Distribution - US Distribution to the states of :CA, FL, IA, ID, and TX., and to the countries of : Austria, Italy, Malaysia, Philippines, Sweden, and United Kingdom
Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, and WV., and to the countries of : Australia, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Greece, Hong Kong, India, Israel, Italy, Japan, Morocco, Portugal, South Korea, South Africa, Spain, Taiwan, Turkey, United Kingdom, Vietnam, and Switzerland.
Worldwide Distribution - US Nationwide GB, NL, DE, IT, FR, BE, ES, NO, CZ, BG, SE, AT, CH, PL, RU, FI
Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.
Product was shipped to the following states: AL, AZ, CA, FL, IL, IN, MN, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT & WI. Product was also shipped to Canada.
Worldwide Distribution- Nationwide distribution to states of: FL, OK, VA, MI, TH, NM, MA, MO, WA, AND country of: Australia.
Worldwide Distribution - US Distribution to the states of : MI, IL and TX., and to the countries of : Greece, Australia, Czech Republic, Hungary, Norway, Brazil, Italy, Switzerland ,UK, Austria, Slovenia, Croatia, Poland, Germany, Japan, France, Netherland, Sri Lanka, Pakistan, Bangladesh, and Israel
To distributors in NC, CA, NY, IA, PA, CT, TX, NJ, KS, KY. IL:. CO 7 Distributors at multiple addresses.
The product was distributed thru out the United States. The firm took orders for the product via internet.
Product was distributed to retail grocery stores in Missouri, Illinois, and Indiana.
Distribution to retail grocery and retail grocery distributors in MD, VA, PA, DE, NY, NJ, NE and DC. Number of direct retail grocery accounts who received affected product: 80, and Micheles Granola website
Distributed throughout the United States

Product Description
Samsung GU60A system- Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications
LX3 Floor Stand for LuxOR Ophthalmic Microscope; Endure LuxOR Q-VUE Ophthalmic Microscope. LX3 Microscope Floor Stands are not stand-alone medical devices, but are used in combination with the LuxOR Ophthalmic Microscope and the LuxOR Ophthalmic Microscope with Q-VUE 3-D Assistant Visualization. These microscopes are used for low magnification visualization during cataract, retina, and cornea surgeries
CADD(R) Medication Cassette Reservoir with clamp and female Luer. Non vented stopper included, REF 21-7002-24, Rx only, STERILE EO, Manufacturer Smiths Medical ASD, Inc.
. Included in First Aid Kits: 36M - Delmarva Power/ACE - w/Logo, Certified Safety Manufacturing logo, and sold blank. product Usage: Provides sterile environment to protect patient from infection
Neusoft NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
Neusoft Medical NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from either the same axial plane taken at different angles or spiral planes taken at different angles.
HEALTH WARRIOR CHIA BAR APPLE CINNAMON NT WT 25 g (.88 g) ALLERGENS: Contains Tree Nuts (Cashews and Almonds)
HEALTH WARRIOR CHIA BAR VANILLA ALMOND NT WT 25 g (.88 g) ALLERGENS: Contains
HEALTH WARRIOR CHIA BAR COCONUT NT WT 25 g (.88 g) ALLERGENS: Contains Tree Nuts (Almonds, Cashews, Coconut)
HEALTH WARRIOR CHIA BAR ACAI BERRY NT WT 25 g (.88 g) ALLERGENS: Contains Tree Nuts (Cashews)
HEALTH WARRIOR CHIA BAR DARK CHOCOLATE NT WT 25 g (.88 g) ALLERGENS: Contains Tree Nuts (Almonds, Cashews). Produced on equipment that also processes other tree nuts, peanuts, soy, wheat and milk.
ISS ONE Blueberry Cobbler Flavored Protein Bar NET WT 2.12 oz (60 g) ALLERGY ALERT: This Contains Milk, Almonds and Soy (Lecithin), This Product is Manufactured in A Facility That Processes Peanut, Tree Nut and Wheat Ingredients
ISS ONE Salted Caramel Flavored Protein Bar NET WT 2012 oz (60 g) ALLERGY ALERT: This Contains Milk, Almonds and Soy (Lecithin). This Product is Manufactured in A Facility That Processes Peanut, Tree Nut and Wheat Ingredients
MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.
Toshiba America Medical Systems Ultimax Digital Fluoroscopic X-Ray System Model: DREX-UI80 Ultimax is intended for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy. The system has medical applications ranging from but not limited to: contrast-enhanced studies, support of endoscopic studies, nonvascular contrast-enhanced studies, nonvascular IVR, vascular contrast-enhanced studies support of vascular NR, and general radiography.
Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert. The Alere iScreen Dx Drug Screen Card is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes monoclonal antibodies to selectively detect elevated levels of specific drugs in urine
mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate and deflate and a medical grade tablet PC to run the software. The software is not included in the recall, only the balloon catheter component.
POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, WITH SIDE PORT, REF Numbers: a) ENF-Y50P-40 b) ENF-Y50P-50 c) ENF-Y60P-40 d) ENF-Y60P-50 e) ENF-Y60P-90 f) ENF-Y80P-40 g) ENF-Y80P-50 h) ENF-Y80P-80 i) ENF-Y80P-90 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.
POLYURETHANE ENFit(R) AMERITUS NG FEEDING TUBE, REF Numbers: a) ENF-50P-40 b) ENF-50P-50 c) ENF-50P-80 d) ENF-60P-40 e) ENF-60P-50 f) ENF-60P-80 g) ENF-80P-40 h) ENF-80P-50 i) ENF-80P-80 j) ENF-100P-110 For pediatric and Neonatal Use, ENFit ENTERAL USE ONLY, RADIOPAQUE STRIPE, STERILE, EO, SINGLE USE ONLY, QTY 10/BOX.
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: Allows for the differentiation of white blood cells, facilitates the characterization of red blood cells and platelets, and aids in the identification of blood components and cellular abnormalities.
Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bottle containing 30 mL with an oral syringe, Rx Only, Manufactured by: Tris Pharma, Inc. Monmouth Junction, NJ 08852, NDC 27808-082-01
Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native arteries or synthetic grafts. The device are designed to facilitate clots too resistant to be removed by an elastomeric balloon. The device features a spiral-shaped, latex-covered stainless steel cable that assumes a corkscrew shape when retracted, greatly expanding the surface areas to entrap fibrous material. The device is 80 cm in length and is available in 4F-6F diameters.
Caribena yellow maradol papaya packed in 35 pound cases
smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the screw at the tip of the instrument, and the stem is then impacted into the femur. After impaction, the surgeon uses a knob at the end of the cardan to unscrew the implanted stem from the instrument
CORN TREATS CONCENTRATED CARAMEL CORN MIX NET WT 1 LB-6 OZ (22 OZ or 623 g) Manufactured by GOLD MEDAL PRODUCTS CO.
needle), larger syringe (3mL), and larger amount of heparin (113IU), than what is intended for the kit.
Amrita Sunflower Butter & Jelly 15g Protein Bar, 60gm UPC: 853009004414
Amrita Dark Chocolate Quinoa 15g Protein Bar, 60gm UPC: 853009004438
Amrita Chocolate Chip Coconut 15g Protein Bar, 60gm UPC: 853009004391
Amrita Apricot Strawberry Protein Bar, 50gm UPC :853009004056
Amrita Cranberry Raisin Energy Bar, 50gm UPC: 853009004032
Amrita Mango Coconut Energy Bar, 50gm UPC: 853009004018
Amrita Apple Cinnamon Energy Bar, 50gm UPC: 853009004049
Amrita Chocolate Maca 15g Protein Bar, 60 gm UPC: 853009004056
Amrita Pineapple Chia Energy Bar, 50gm UPC: 853009004025
Papayas Maradol cavi, Grown and Packed by: CARICA DE CAMPECHE, DISTRIBUTED BY: AGROSONS LLC
CIVCO Arm Support, REF 106047, distributed as: (a) Rigid Arm Support, Large, Set, Red (PN: 106047) (b) PB2-BDLRL (PN: 109040) (c) Rigid Adj. Arm Support, Large, Set (PN: 106048) (d) PSR2-CF-DLRL-2P Posirest-2 (PN: 106522) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment.
CIVCO Arm Support, REF 106015, distributed as: (a) Rigid Arm Support, Standard, Set Red (PN: 106015) (b) Rigid Adj. Arm Support, Set (PN: 106020) (c) PSR2-CR-DLR-2P Posirest-2 (PN: 106521) (d) PB2-BLR Posiboard-2 (PN: 109030) The Rigid Arm Supports are utilized on the Posibboard2 and Posirest assemblies, which are intended to position the patients upper extremities during breast and lung diagnostic and radiotherapy treatment..
Valery Brand Maradol Papayas sold fresh in 35 pound boxes. Labeled grown and packed by Carica de Campeche
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to , pediatric and obese patients. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis
Mary's Gone Crackers Original Crackers: Organic, Gluten Free, Non-GMO, Vegan. 6.5 oz. (184 g) box; Ingredients: Whole grain brown rice, whole grain quinoa, brown flax seeds, brown sesame seeds, filtered water, sea salt, wheat free tamari (water, whole soybeans, salt, vinegar). Contains: Soy. Unit UPC: 8 97580 00010 6; Case UPC: 8 97580 00030 4;
Bourbon Street Mix, 157 25 lbs cases and 2,509 one (1) lb bags.
German chocolate cakes labeled as Schnucks Bakery Deluxe Petite Cake Chocolate Iced Yellow, Net Wt. 1 lb 1 oz (482 g), UPC 0 41218 31168 6
Micheles Toasted Muesli, 16 oz bags, 12 units per case
CARLA'S PASTA, INC. BASIL PESTO SAUCE: BULK, Mfd. Date 06/20/17, KEEP FROZEN NET WT. 13.40 LBS (6.08 kg) 00021605014209
MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58
Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only, Manufactured By: Cipla Ltd. at Medispray Laboratories Pvt. Ltd., Kundaim Goa, India; Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054, NDC 60432-065-00.
4-count boxes of KIND Breakfast Dark Chocolate Cocoa Bars 1.76 oz (50g) Outer Box: UPC: 60265220102-8
(a) SEVEN SUNDAYS VANILLA CHERRY PECAN MUESLI 12oz. pouch, UPC: 8-56088-00315-6 (b) SEVEN SUNDAYS VANILLA CHERRY PECAN MUESLI 2oz. cup UPC: 8-56088-00311-8
Dude Products Facial Wipe, 3 in 1, 30 count per pack
Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL single-dose vials, Rx only, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, CA 91730, NDC 0548-9021-00
Blood and Blood Products for Reprocessing

Product Quantity
1,988 cases (12 x 6.5 oz. boxe per case).
26,328 consumer units (outer carton boxes)

Reason for Recall
When performing the Stitching function on GU60A system, unintended area is exposed to radiation
Multiple shipments or forceful impact to a caster on a LuxOr/LX3 microscope may stress the microscope base, which could contribute to a caster breaking or detaching from the base.
The medication cassette reservoir, part number 21-7002-24, with lot number 16X659, may have been manufactured with the incorrect pressure plate and the tubing used on the cassette may have been routed incorrectly.
Burn Sheet has possibility of being shredded.
Ingredient used in the manufacture of these products was recalled due to a potential for Listeria monocytogenes contamination.
The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam.
The issue was identified as a firmware problem with the generator.
The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled correctly.
Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon from the inner stem, leaving it in the rectal cavity.
Inadequate detectability of radiopaque stripes
The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation.
Defective container: Oral solution leaking from container.
The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.
The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
Missing ingredient statement on the label and undeclared soy.
Blood product, mislabeled as crossmatch compatible, was distributed.
Product may be contaminated with Listeria monocytogenes
Product may be contaminated with Salmonella.
Rigid Arm Supports (PN: 106015 and 106047), which were used as part of the Posiboard-2 and Posirest, and were distributed as PN: 106015, 106047, 106521, 106522, 109030, and 109040 between Ocotober 2009 and July 2012 may have a height difference of approximately 17mm.
The recalling firm received papayas from a Mexican grower associated with an outbreak of Salmonella.
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.
Recall of crackers due to pieces of blue grade plastic liner found inside the packaged cracker product.
According to the firm ( Nuts.com) undeclared cashews were in the Bourbon Street Mix. The firm learned of the problem through a customer complaint. The firm is doing a recall of the product due to undeclared allergens.
German Chocolate cakes were labeled as Chocolate Iced Yellow Cake. German Chocolate contains pecans that are not listed on the Iced Yellow Cake label.
The product has been recalled due to the potential to be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.
It was reported that the models used to manufacture S-200956/958 had the wrong dimension used to create the spherical radius cutting surface. Device design allows a larger spherical radius cutting surface than intended.
Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Mislabeled Outer Box labeled as : KIND Breakfast Dark Chocolate Cocoa Bars may contain KIND Breakfast PROTEIN Dark Chocolate Cocoa Bars.
Product labeled containing pecans actually contains almonds
Firm received complaints of mold on Dude Products Facial Wipe
Crystallization: Particulate matter (Ketorolac Calcium Salt) was observed from several lots of retained samples.
Blood product, for which unit sterility was compromised during collection, was distributed.
Blood products, collected from an ineligible donor, were distributed.

Code Info
Burn Sheet: Dukal Part # 7305, 30-01, CSM Part # R505-091. First Aid Kit: CSM Part # K608-061 36M. Burn pad lot numbers: JT36112, JT09113, JT17513.
NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P16 or previous version
NeuViz 64 Multi-slice CT Scanner System, including: NeuViz 64e, NeuViz 64i with software version 1.0.6.3258 +P11 or previous version, NeuViz 64En, NeuViz 641n with software version 1.0.7.4021+P11 or previous version
Reference No. DYNJP2229S; Lot/Serial No. 45016070513PH
a) ENF-Y50P-40, lot number KS1608011 b) ENF-Y50P-50, lot number KS1608012 c) ENF-Y60P-40, lot number KS1608013 d) ENF-Y60P-50, lot number KS1608014 e) ENF-Y60P-90, lot number KS1608015 f) ENF-Y80P-40, lot number KS1606035 g) ENF-Y80P-50, lot number KS1606036 h) ENF-Y80P-80, lot number KS1606037 i) ENF-Y80P-90, lot number KS1606038
a) ENF-50P-40, lot number KS1606031 b) ENF-50P-50, lot number KS1606028 c) ENF-50P-80, lot number KS1608007 d) ENF-60P-40, lot number KS1608008 e) ENF-60P-50, lot number KS1606029 f) ENF-60P-80, lot number KS1608009 g) ENF-80P-40, lot number KS1606032 h) ENF-80P-50, lot number KS1606030 i) ENF-80P-80, lot number KS1606034 j) ENF-100P-110, lot number KS1608010
Best Buy date between 04/24/2018 to 05/31/2018
All Valery Brand Maradol papayas distributed from July 10 to July 13, 2017.
Artis zee biplane MN- Serial number: 149402 149401
Artis zee floor MN - Serial number: 140221 140226 140406
Best by date between 8/12/17 through 8/14/17
Best Before Date of 03/05/2018 and only Lot Code BK17156A2 (Outer Box)
a)LOT CODES: JUNE 29,2018 & AUGUST 11,2018 (b) LOT CODES: AUGUST 11, 2018