Recalling Firm
Maquet Datascope Corp - Cardiac Assist Division
Southeastern Mills Custom Seasoning Solutions

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 to countries of: Germany, Switzerland, turkey and UAE.
US Distribution to the state of : Illinois
US Distribution to the states of : CA, FL, GA, KS, MI, NJ, OH, PA, SC, and TX.
Worldwide distribution. US nationwide to AK, AL, AR, AZ, CA, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia, Hawaii and Puerto Rico. ALBANIA, ALGERIA, ANTIGUA AND BARBUDA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BENIN, BOTSWANA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, FINLAND, FRANCE, GABON, GEORGIA, GERMANY, GHANA, GREECE, HONDURRAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, LAOS, LIBYA, LITHUANIA, MALAYSIA, MALTA, MEXICO, MOROCCO, MYANMAR, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, VENEZUELA, VIETNAM and ZIMBABWE
Worldwide Distribution - US (nationwide) Internationally to Albania, Algeria, Andorra, Angola, Antigua and Barbuda, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Bulgaria, Burundi, Canada, China, Colombia, Congo, Croatia, Czech republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, india, Indonesia, Italy, Japan, Iraq, Jordan. Kenya, Kuwait, Libya, Lithuania, Macau, Lebanon, Macedonia, Malawi, Malaysia, Mexico, Mongolia, Morocco, Mozambique, Netherlands, New Zealand, Nigeria, Pakistan, Panama, Paraguay, Philippines, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, UAE, UK, Uruguay, Venezuela, Vietnam, Virgin Islands, Yemen, Zambia, Zimbabwe.
Worldwide Distribution - US Nationwide International: AFGHANISTAN, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALDIVES, MALTA, MAURITIUS, MEXICO, MOROCCO, MYANMAR, NEPAL, NETHERLANDS, NEW ZEALAND, NORTH KOREA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TUNISIA, TURKEY, TURKMENISTAN, UGANDA, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM & YEMEN.
Distribution was made to medical facilities located in AZ, CA, CO, MA, MI, MN, MO, NY, OH UT, VA, and WI. There was no foreign/military/government distribution.
Worldwide Distribution - US (Nationwide) and Internationally to Canada
Domestic Only: IL, MN, WI, IN, FL, MI, and TX NO VA/DOD
distributed in CA, CO, IA, ND, NE, OR, and WA.
Domestic: AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, MT, NC, MD, NE, NV, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI and WV; Foreign: Canada.

Product Description
Cocolicious Beef and Turkey, Size: 13 ounce cans
Cocolicious Chicken and Beef, Size: 13 ounce cans
Timolol-Brimonidine-Dorzolamide-Latanoprost (0.5/0.15/2/0.005)% Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
Timolol-Latanoprost PF Solution (0.5-0.005)%, Ophthalmic Drops, Sterile 5ml Bottle, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
Latanoprost PF Solution, 0.005%, Ophthalmic Drops in Sterile 5ml Bottles, Compounded for a licensed professional or patient use, imprimisRx, Irvine, CA
Curcumin Emulsion 10mg/ml Injection, Sterile 10 mL Multiple Dose Vial, For Slow IV Administration, Compounded for a licensed professional or patient use by ImprimisRx, Irvine, CA
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic disease.
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
MOSAIQ Medical Charged-Particle Radiation Therapy System
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and media interchange of medical images from a variety of diagnostic imaging systems
Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The purpose of the LH 700 Series is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patients condition. The purpose of the LH 500 Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, or any other test that aids in diagnosing an abnormality
Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell distribution, biochemical investigation or any other test that helps diagnose the abnormality
CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.
CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.
CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic pressure promotes more blood flow through the coronary arteries. Left ventricular work is reduced by decreasing aortic end diastolic pressure and reducing resistance to ventricular ejection, resulting in a decrease in blood pressure during the systolic phase of the cardiac cycle.
MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures
Gazab Green Raisins, 7 oz. 14 oz. packages, 20/25 packs/carton
Madhava Naturally Sweet Deliciously Organic MMM... Chocolate Chip Cookie Mix,, 13.8 oz. , UPC 0 78314 25105 0. Packaged in box, 6 packages per case, Ambient storage.
Whole Foods Smoked Peppered Atlantic Salmon Portion, packed in bulk boxes. Labeling states: Smoked on: 08/09/17, Sell Through: 09/04/17. Smoked fish portions are placed inside of a box lined with a plastic bag, which is hand-tied when the box is filled. Weights of each box vary.
Whole Foods Smoked Traditional Atlantic Salmon Portion, packed in bulk boxes. Labeling states: Smoked on: 08/09/17, Sell Through: 09/04/17. Smoked fish portions are placed inside of a box lined with a plastic bag, which is hand-tied when the box is filled. Weights of each box vary.
Whole Foods Smoked Whitefish Fillet, packed in bulk boxes. Labeling states: Smoked on: 08/09/17, Sell Through: 09/04/17. Smoked fish portions are placed inside of a box lined with a plastic bag, which is hand-tied when the box is filled. Weights of each box vary.
Southeastern Mills, Easy Drop Cheddar Garlic Drop Biscuit Mix, Net Wt. 7oz (198g).
Southeastern Mills, Buttermilk Drop Biscuit Mix, Net Wt. 7.4 oz. (210g).
Southeastern Mills, Country Biscuit Mix, Net Wt. 6oz (170g).
Shore Lunch, Fish Breading Batter Mix, Original Breading, Net Wt. 3.5 lbs. (1587g) and12/255 G (Canada).
Southeastern Mills, Biscuit Gravy Mix, Net Wt. 2.75oz (77g), 4.5oz (128g) flexible plastic packages.
Shore Lunch, Fish Breading Batter Mix, Cajun Style Breading, Net Wt. 9oz (255g)
Apheresis Red Blood Cells, Leukocytes Reduced
Red Blood Cells, Leukocytes Reduced, Irradiated
Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose cards (100-count box), Rx only, Manufactured By: Watson Pharmaceuticals 311 Bonnie Circle Corona, CA 92880, NDC 63739-509-10
Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA, NDC 68180-150-01
Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Manufactured for PSS World Medical, Inc. Southpoint Blvd. Jacksonville, FL Made in Mexico, NDC 68345-350-09
Blood and Blood Products for Reprocessing
Cyclosporin 2% Ophthalmic Drops, 15mL bottles

Product Quantity
98 sites have the potentially affected software
14,547 units (5,049 domestically & 9,498 units internationally)
14oz - 27 cases (675 pcs were packaged) / 7oz 44.48 cases (1,112 pcs were packaged)
Total 72,805 units (includes the following types of units: 21,430 bags, 5,654 bales, 44,953 cases, 768 cases into shippers).

Reason for Recall
Party Animal is recalling canned dog foods because they tested positive for pentobarbital.
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Specific lots have been reported to produce falsely lower than expected results for Vitamin D
Mix-up RGA (Return Goods Authorization) leading to 5 devices being redistributed and implanted 2 patients.
Three (3) complaints were identified in which the potential for utilization of the JTS Grower Drive in the incorrect orientation in relation to the limb entry point of the device, together with the potential to select incorrect settings for the extension procedure. As a result, the prostheses in such cases failed to extend as intended.
The table shift in the vertical direction was inverted during the use of CMA (Couch Move Assistant). Therapy may be directed to an incorrect area.
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples.
Blood product, which did not meet the acceptable product specifications, was distributed.
False blood back detection alarm and the ingress of fluids into the IABP affecting various electronic circuit boards could potentially prevent initiation or continuation of therapy.
There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.
United Trading Inc., has initiated a voluntary recall of Gazab Green Raisins, due to undeclared sulfites.
Madhava Natural Sweeteners is recalling MMM... Chocolate Chip Cookie Mix because it may contain undeclared milk.
Rushing Waters Fisheries is recalling 3 smoked fish products because they may have been underprocessed.
OPA by Litehouse Ranch was recalled due to undeclared egg.
Products were manufactured from raw material (buttermilk solids) that may potentially be contaminated with Salmonella.
Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.
Blood product, in which quality control for WBC count was not performed, was distributed.
Failed moisture limits: Out of specification for moisture content.
Source Plasma, collected from an ineligible donor, was distributed.
Source Plasma, collected from an ineligible donors, was distributed.
Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% , the outer box had the correct label.
Blood product, collected from an unsuitable donor due to a donor screening deviation, was distributed.
Lack of sterility assurance for compounded veterinary product.
Source Plasma, collected from ineligible donors, were distributed.

Code Info
Lot Number: 0136E15204 04 Best By Date: July 2019
Lot Number: 0134E15 237 13 Best By Date: August 2019
Software versions 10.0, 10.0.1, 10.0.2, 10.0.3, 10.0.4, 10.0.5, 11.0, 11.0.1, 11.0.2, 11.0.3, 11.0.4, 11.1, 11.1.1, 11.1.1.1, 11.1.1 Patch 2, 11.1.1 Patch 3, 11.1.2, 11.1.2 Patch 1, 11.1.2 Patch 2, 11.1.2 Patch 3, and 11.1.2 Patch 4. Only customers with one of the above listed software versions AND a license for Mammo Tracking are impacted by this recall.
Gazab Green Raisins, Lot#: SBN1612, Sanitary #6500D00045, MFD: 11-22-2016
The following codes are observed on the lid: Best by OCT 24 17. 13948
Lot/Batch number: 02242016@37 Beyond Use Date: 5/24/16