AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA MD, MI, MN, MO, MT, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WV.  Internationally to: Australia, Chile, Cost Rica, Ecuador, Netherlands, Panama & Switzerland
DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
A raw material anomaly was discovered in four lots of raw material and has the potential to be on or below the surface of the device components which can increase the risk of instrument fracture
Accu2i pMTA  Applicator, 29 cm LONG, REF/Catalog # 900-601, Model # (UPN) H7879006010, STERILE  --- This is only for use with a Sulis V Generator, REF 806-10.    Product Usage:  The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
The firm is recalling product that has the potential to not function during use.   The product affected by this recall will not deliver the desired microwave energy due to coolant ingress in an electrical connection; this condition results in an error code High Reflective Power displayed on the microwave generator.
Accu2i pMTA  Applicator, 14 cm STANDARD, REF/Catalog # 900-600-US, Model # (UPN) H787900600US0, STERILE  --- This is only for use with a Sulis V Generator, REF 806-10.    Product Usage:  The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
Accu2i pMTA  Applicator, 29 cm LONG, REF/Catalog # 900-601-US, Model # (UPN) H787900601US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10.    Product Usage:  The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
Accu2i pMTA  Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602, Model # (UPN) H7879006020, STERILE --- This is only for use with a Sulis V Generator, REF 806-10.    Product Usage:  The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
Accu2i pMTA  Applicator, 19 cm INTERMEDIATE, REF/Catalog # 900-602-US, Model # (UPN) H787900602US0, STERILE --- This is only for use with a Sulis V Generator, REF 806-10.    Product Usage:  The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
Accu2i pMTA  Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN) H7879006000, STERILE --- This is only for use with a Sulis V Generator, REF 806-10.    Product Usage:  The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue.
US Nationwide distribution including Puerto Rico
The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule.
Nationwide within U.S.A and Puerto Rico; International: Australia, Brazil, Canada, China, Germany, India, Japan, Netherlands & Singapore
Zimmer Natural Nail System Tear Drop Guide Wire  2.4 mm Diameter, 70 cm length, Item Number 47-2490-098-01    Product Usage:  The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide wire incorporates either a ball or tapered tip to aid in removal of the intramedullary reamer if it becomes lodged or fails.
The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed.
All Lot Numbers  Expiry  Date Before March 2022
Zimmer Natural Nail System Tear Drop Guide Wire  3.0 mm Diameter, 70 cm length, Item Number 47-2490-098-00    Product Usage:  The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide wire incorporates either a ball or tapered tip to aid in removal of the intramedullary reamer if it becomes lodged or fails.
All Lot Numbers  Expiry Date Before April 2022
M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-025-00    Product Usage:  The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide wire incorporates either a ball or tapered tip to aid in removal of the intramedullary reamer if it becomes lodged or fails.
All Lot Numbers   Expiry Date Before April 2022
Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-008-00    Product Usage:  The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide wire incorporates either a ball or tapered tip to aid in removal of the intramedullary reamer if it becomes lodged or fails.
M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-026-00    Product Usage:  The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide wire incorporates either a ball or tapered tip to aid in removal of the intramedullary reamer if it becomes lodged or fails.
All Lot Numbers  Expiry Date Before March 2022
Arabia, Australia, Israel, Brunei & Jamaica
The kit was packaged with the incorrect introducer needle size.  The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip.
Fresh Cilantro BRENCKLE FARMS INC Hartville, Ohio
Firm was notified that the product contains Listeria monocytogenes
Philips Electronics North  America Corporation
No U.S. distribution, Internationally to: India, Ireland, Japan, Republic of Korea, Malaysia, Mexico, South Africa & United Kingdom
MRx Defibrillator Model # M3535A & M3536A, UDI 00884838000018(21)US00601969    Product Usage:  The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
Affected units may have a defective component that is intended to protect the internal circuitry from high voltages during shock delivery.  The defective component may also prevent delivery of shocks in AED mode.
Medtronic Ascenda(R) Intrathecal Catheter, Models:  (a) 8780, UDI:  00643169202122, 00643169783027  (b) 8781, UDI:  00643169202139  (c) 8784, UDI:  00643169202153    The Ascenda Intrathecal Catheter kits (models 8780, 8781 and 8784) contain parts of an infusion system that delivers drugs to the intrathecal space. The implanted system consists of an implantable infusion pump and an Ascenda catheter. The catheter connects to the pump at the catheter port and enters the intrathecal space.
There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the catheter connects to the drug infusion  pump.
Disposable Light Handle Cover, Item Number B1-715-65.  Packaged 1 device inside a peel pouch and sealed.  Sealed pouches are packaged 10 each inside a poly liner.  5 rows of 10 pouches are placed in a labeled corrugated mailer box.     Product Usage:  Intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. Single use device.
Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.
3m Center 2510 Conway Ave , B# 275-5-W-6
AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN,  KS, KY, LA, MD, MI, MO, MS, NC, NH, NY, OH,  OR, PA, SC, TN, TX, UT, VA, WI, WV
ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9
Mold was found on the non-patient contact  surfaces of the product and was identified as  Aspergillus candidus.
Nationwide Distribution - AK, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, and WI.
SUR-FIT Natura Moldable Durahesive Skin Barrier with Hydrocolloid Flexible Collar, 10 pack, 45 mm, REF 411802.    Intended for use as an ostomy protector providing a protective barrier to patient skin.
47,630 units (4,763 market units, 10 per pack)
A portion of Lot 7H02242 outer boxes (market units) of the SUR-FIT Natura Moldable Durahesive Skin Barrier (10 pack, 45 mm, REF 411802) were incorrectly labeled as Natura Moldable Stomahesive  Skin Barrier (10 pack, 45 mm, REF 411803).
ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack.  Siemens Material Number (SMN): 10379810, 10379811, 10697756.
Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT systems when calibrating with Calibrator 30 kit lots ending in 21 (C3021) as compared to Calibrator 30 kit lots ending in 20 (C3020).
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blackberry Pie Baked whole pies, Baked 1/2 pies & Frozen pies, Stevens Bakery & Orchard 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
Product contains undeclared milk - label failed to include the components of butter in the ingredient statement.
Baked whole pies = BEST USED BY NOV 07 2017, BEST USED BY NOV 08 2017, Baked 1/2 pies = BEST USED BY NOV 08 2017 & Frozen pies = No BEST USED BY date
Apple Streusel Pie - Baked whole/half pies and Frozen pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
No Sugar Added Apple Pie Baked 1/2 pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
Product contains undeclared milk (label failed to include the components of butter in the ingredient statement) and failed to include the warning statement for aspartame for their No Sugar products.
Baked 1/2 pies = BEST USED BY NOV 08 2017
Pecan Pie Baked whole pies, Baked 1/2 pies & frozen pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
38 whole pies, 12 1/2 pies & 4 frozen pies
Baked whole pies = BEST USED BY NOV 07 2017, BEST USED BY NOV 08 2017 & Baked 1/2 Pies = BEST USED BY NOV 08 2017 & Frozen pies = No BEST USED BY date
No Sugar Added Pumpkin Pie Baked whole pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
Product label failed to include the warning statement for aspartame for their No Sugar products.
Baked whole pies = BEST USED BY NOV 07 2017
Strawberry Pie Baked whole/half pies & frozen pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
Baked whole pies = BEST USED BY NOV 08 2017 & Frozen pies = No BEST USED BY date
Cherry Pie Baked whole pies, Baked 1/2 pies & Frozen pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
Baked whole pies = BEST USED BY NOV 07 2017, BEST USED BY NOV 08 2017, Baked 1/2 pies =BEST USED BY NOV 08 2017 & Frozen pies = No BEST USED BY date
Toll House Pie Baked whole/half pies & frozen pies, Stevens Bakery & Orchard ,7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
Lemon Pie Baked whole pies, Baked 1/2 pies & Frozen pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
Product contains undeclared wheat and milk.
Peach Pie Baked whole pies & Baked 1/2 pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
Baked whole pies = BEST USED BY NOV 07 2017, BEST USED BY NOV 08 2017 & Baked 1/2 Pies = BEST USED BY NOV 08 2017
Rhubarb Pie Baked whole pies & frozen pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
Sugar Cream Pie Baked whole/half pies & frozen pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
Product contains undeclared milk - label failed to include the components of butter and cream in the ingredient statement.
Apple Top Pie Baked whole pies, Stevens Bakery & Orchard, 7344 Thackery Road, Springfield, Ohio 45502, (937) 788-2873
All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate  Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
All lots remaining within expiry (BUDs between November 15, 2017 and December 16, 2017)
All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
All lots remaining within expiry (BUD between November 15, 2017 and December 16, 2017).
All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base  Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
All lots remaining within expiry (BUDs between November 15, 2017 and December 16, 2017).
All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173    Product Usage:  Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications.
When a prior study is being replaced in the workflow step, in certain scenarios (based on the Display Protocol configuration) the prior study will only be replaced in the active Workflow Step and not show in all other workflow steps. The other workflow steps will continue to show the initially loaded study.
Product was distributed nationwide in the USA
Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00
Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass
Worldwide Distribution-US (Nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, El Salvador, Hong Kong, India, Indonesia, Malaysia, Mexico, Panama, Peru, Argentina, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay & Vietnam.
The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.
Product was distributed throughout United States.
Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis products, in which residual WBC count was not performed, were distributed.
Sister Schubert's Rolls Division of T.Marzetti Company
Product was shipped to the following states: AL, CA, FL, GA, IN, KY, LA, NC, PA, SC TN, TX & VA.
Southern Style Frozen Biscuits sold under the following brand names: Food Club, Food Lion, Laura Lynn, Lowes Foods, Marshalls, Morning Fresh Farms, Piggly Wiggly, Premium Pick 5, SE Grocers, Shur Fine, Southern Home & Valu Time
Firm was notified by their supplier of a positive test result for Listeria monocytogenes.
All product shipped between 4/11/2017 - 12/21/2017
Survey No. 314, Bachupally, Quthbullapur
Ampicillian and Sulbactam for Injection 1.5 g vial, sterile  Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Red Blood Cells, Leukocytes Reduced, Irradiated
Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Apheresis Red Blood Cells, Leukocytes Reduced
Blood products, which did not meet the acceptable product specifications, were distributed.
Philips Brilliance 64 computed tomography x-ray system
Numerous issues related to software   Brilliance iCT 4.1.6 software version.
Philips Ingenuity Core 128 computed tomography x-ray system
Philips Ingenuity CT computed tomography x-ray system
Philips Ingenuity Core computed tomography x-ray system
Blood Systems, Inc. dba United Blood Services Texas
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood product, collected in a manner that may have compromised the sterility of the collection system, was distributed.
US Distribution to the states of : CO and ND
VNS(R) Therapy Programmer, GMDN:  44077, Model 3000 v1.0.2.2      Intended Use/Indications: United States Indications for Use: Epilepsy : The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications. Depression : VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
Two Model 3000 Programmers were distributed in error by prior to FDA approval of version 1.0.2.2 software.
Implant Direct Sybron Manufacturing, LLC
CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands
Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.
Blood product, which did not meet the acceptable product specifications, was distributed.
Pan con pasas [Bread with raisins] NET WT 1LB (16OZ)
Undeclared allergens: wheat, soy, and egg.
Bizcocho de Vainilla con Queso [Vanilla Cake with Cheese] NET WT 4OZ and 12OZ
Undeclared allergens: wheat, soy, milk, Yellow # 5, and Yellow # 6.
Bizcocho de Vainilla con Guava [Vanilla Cake with Guava] NET WT 4OZ and 12OZ
Undeclared allergens: wheat, soy, milk, Red # 40, and potassium sorbate.
Undeclared allergens: soy, potassium sorbate.
Undeclared allergens: wheat, soy, and milk.
Bizcocho Zanahoria [Carrot Cake] NET WT 4OZ
Undeclared allergens: wheat, soy, eggs, and milk.
Bizcocho Vainilla con Queso y Guava [Vanilla Cake with Cheese and Guava] NET WT 12OZ
Undeclared allergens: wheat, soy, Yellow # 5, Yellow # 6, Red # 40, and potassium sorbate.
Distributed to retailers in IA, KS, and NE
Tampico Citrus Punch, 1 GAL (3.78 L) Tampico Beverages, Chicago, IL
Milk allergen was detected in one lot of orange juice and one lot of citrus drink. Milk is not an ingredient declared on the label.
Hiland Orange Juice, 1 GAL (3.78 L) Hiland Dairy, Springfield, MO.
Distributed to 20 retail stores in Utah.  No foreign/VA/govt/military consignees.
Rico Tofu Breakfast Burrito, 12 oz, wrapped in white paper. Frozen.
Rico Brand is recalling Tofu Breakfast Burrito because it contains undeclared soy.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
US Distribution was made to CA.  There was no foreign/military/government distribution.
Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A    Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings
49 kits to the U.S. office  (32 kits further distributed)
The low and high controls for the product are returning results above the assigned values.
US Distribution to the states of :  AL, CA, CO, FL, MD. and NY
Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5      All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Exactech Alteon HA femoral stems are intended for press-fit fixation.
Wrong device description of the label identifying the implant
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Safety-Deluxe Basic Soft Tissue Biopsy Tray without Biopsy Needle, Catalog # 977    Product Usage:  Surgical procedure
BD SafetyGlide Needle 22GA 1-1/2 inch may contain the presence of loose polyprophylene foreign matter above release specification.
Lot Numbers/Expiration Dates:  1) 1610197/Expiration Date: 12/01/2018;  2) 1610277/Expiration Date: 03/01/2019
Safety-Deluxe Lumbar Puncture Tray, Catalog # 975    Product Usage:  Surgical procedure
Lumbar Puncture Tray, Catalog # 1862    Product Usage:  Surgical procedure
Lot Numbers/Expiration Dates:  1) 1710206/Expiration Date: 05/30/2022;  2) 1710040/Expiration Date: 01/30/2022;   3) 1610536/Expiration Date: 12/30/2021;   4) 1610423/No Expiration Date;  5) 1610351/No Expiration Date;  6) 1610219/No Expiration Date;   7) 1610090/No Expiration Date
Safety Deluxe Bone Marrow Biopsy/ Aspiration Tray with Biopsy Needle and Aspiration Needle Sterile, Catalog # 985    Product Usage:  Surgical procedure
Lot Numbers/Expiration Dates:  1) 1720047/Expiration Date: 02/20/2018
Laceration Tray, Catalog # 1892R1    Product Usage:  Surgical procedure
Safety Deluxe Bone Marrow Biopsy/Aspiration Tray, Catalog # 986    Product Usage:  Surgical procedure
Lot Numbers/Expiration Dates:  1) 1620888/Expiration Date: 12/30/2017  2) 1620367/Expiration Date: 09/01/2017
Safety-Deluxe Lumbar Puncture Tray, Catalog # 974    Product Usage:  Surgical procedure
Leukoreduced Red Blood Cells, not meeting product specifications, were distributed.
Product distributed to one distribution center which further distributed to retail stores in CO, IA, MN, NE, SD, and WY.
Sea Salt Caramel Hearts, Net Wt 12 OZ (340 g), Made by Palmer Candy Company, Sioux City, Iowa. UPC 77232-17091
During packaging, the firm observed a peanut stuck to the outside of caramel heart. Peanuts are not declared on the label.
Cherry Tomatoes, packaged in a pint sized plastic clamshell, no labeling
Frog Holler Produce initiated a voluntary recall of cherry tomatoes, packaged in a pint sized plastic clamshell due to potential contamination with Salmonella.
No lot codes, best by dates, or identifying labeling; product was distributed between 01/04/2018 and 01/10/2018.
U.S., Gov Accts, and foreign countries: PA, PR, CO.
X-Ray Detectable Sponges Sponge.     product Usage:  Vistec  X-Ray Detectable Sponges are medical absorbent devices intended to be used internally within the body cavity to control bleeding or for applying medication. These sponges contain unique dual-colored elements that combines blue radiopaque strand with white strand, which is visible when sponge is saturated with blood.
x-ray detectable sponges de to possible contamination with human blood caused by handling of the product during the manufacturing process and prior to final packaging and Ethylene Oxide sterilization.
Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080.
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
TITAN, 6 rellenos, Potato Puffs with Meat Flavor, Net Weight 26.4 oz (748g)
Finished product label does not declare Sodium Bisulfite as an ingredient.
TITAN, 24 rellenos de papas, (potato puffs), Net WT 6.75 LB (pounds)
Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only NDC 0469-3211-10 Marketed by: Astellas Pharma US, Inc. Northbrook, IL 60062.
Labeling: Label Error on Declared Strength: Primary package vial label for Mycamine 100 mg incorrectly states the strength as 50 mg micafungin on the side of the primary package label
Wienke's Market Cranberry Cherry Jam, Net Wt. 8 oz (226g), UPC 14106-00218.  Refrigerate after opening.  Ingredients:  cranberries, cherries, sugar, pectin.
Jams and Jellies are made with butter which is not declared on the label.
Jams and Jellies produced prior to January 17, 2018
Wienke's Market Summer Blend Jam,  Packaged in the following sized glass jars:  1.  Net Wt. 8 oz (226g), UPC 14106-00237;  2.  Net Wt 16 oz  UPC 14106-00248.  Refrigerate after opening.  Ingredients:  cherries, strawberries, blackberries, blueberries, red raspberries, sugar, pectin.
Wienke's Market Seedless Black Raspberry Jam, Net Wt. 8 oz (226g), UPC 14106-00204.  Refrigerate after opening.  Ingredients:  black raspberry puree, sugar, pectin.
Wienke's Market Seedless Raspberry Jam, Net Wt. 8 oz (226g), UPC 14106-00228.    Refrigerate after opening.  Ingredients:  raspberry puree, sugar, pectin.
Wienke's Market Rhubarb Jam, Net Wt. 8 oz (226g), UPC 14106-00230.    Refrigerate after opening.  Ingredients:  rhubarb, sugar, pectin.
Wienke's Market Seedless Strawberry Jam, Net Wt. 8 oz (226g), UPC 14106-00232.    Refrigerate after opening.  Ingredients:  strawberry puree, sugar, pectin.
Wienke's Market Seedless Blueberry Jam, Net Wt. 8 oz (226g), UPC 14106-00206.  Refrigerate after opening.  Ingredients:  blueberries, sugar, pectin.
Wienke's Market Strawberry Raspberry Jam, Net Wt. 8 oz (226g), UPC 14106-00235.    Refrigerate after opening.  Ingredients:  strawberries, raspberries, sugar, pectin.
Wienke's Market No Sugar Added Raspberry Jam,  Net Wt. 8 oz (226g), UPC 14106-00312.  Refrigerate after opening.  Ingredients:  raspberries, rice syrup, grape juice, pectin.
Wienke's Market Cranberry Jam, Net Wt. 8 oz (226g), UPC 14106-00217.  Refrigerate after opening.  Ingredients:  cranberries, sugar, pectin.
Wienke's Market Cherry Raspberry Jam, Net Wt. 8 oz (226g), UPC 14106-00215.  Refrigerate after opening.  Ingredients:  cherries, raspberries, sugar, pectin.
Wienke's Market Whole Cherry Jam, Net Wt. 8 oz (226g), UPC 14106-00212.  Refrigerate after opening.  Ingredients:  cherries, sugar, pectin.
Wienke's Market Strawberry Rhubarb Jam,  Packaged in the following sized glass jars:  1.  Net Wt. 8 oz (226g), UPC 14106-00236;  2.  Net Wt 16 oz  UPC 14106-00250.  Refrigerate after opening.  Ingredients:  strawberries, rhubarb, sugar, pectin.
Wienke's Market Currant Jelly, Net Wt. 8 oz (226g), UPC 14106-00219.  Refrigerate after opening.  Ingredients:  currant juice, sugar, pectin.
Wienke's Market Strawberry Banana Jam, Net Wt. 8 oz (226g), UPC 14106-00233.    Refrigerate after opening.  Ingredients:  strawberries, banana, sugar, pectin.
Wienke's Market Boysenberry Jam, Net Wt. 8 oz (226g), UPC 14106-00208.  Refrigerate after opening.  Ingredients:  boysenberries,  sugar, pectin.
Wienke's Market No Sugar Added Cherry Jam,  Net Wt. 8 oz (226g), UPC 14106-00307.  Refrigerate after opening.  Ingredients:  cherries, rice syrup, grape juice, pectin.
Wienke's Market Raspberry Jam, packaged in the following sized glass jars:  1.Net Wt. 8 oz (226g), UPC 14106-00227;   2.  Net Wt. 16 oz (452g), UPC 14106-00247.  Refrigerate after opening.  Ingredients:  raspberries, sugar, pectin.
Wienke's Market Hot Cherry Jam, Net Wt. 8 oz (226g), UPC 14106-00211.  Refrigerate after opening.  Ingredients:  cherries, sweet red peppers, onion, hot peppers, sugar, pectin.
Wienke's Market No Sugar Added Cherry Raspberry Jam,  Net Wt. 8 oz (226g), UPC 14106-00308.  Refrigerate after opening.  Ingredients:  cherries, raspberries, rice syrup, grape juice, pectin.
Wienke's Market Cherry Jelly, Net Wt. 8 oz (226g), UPC 14106-00213.  Refrigerate after opening.  Ingredients:  cherry juice, sugar, pectin.
Wienke's Market Cherry Jam sold in the following sized glass jars:  1.  Net Wt. 8 oz (226g), UPC 14106-00210;  2.  Net Wt. 16 oz (452g) UPC 14106-00499.  Refrigerate after opening.  Ingredients:  cherries,  sugar, pectin.
Wienke's Market Gooseberry Jam, Net Wt. 8 oz (226g), UPC 14106-00220.  Refrigerate after opening.  Ingredients:  gooseberries, sugar, pectin.
Wienke's Market Strawberry Cherry Jam, Net Wt. 8 oz (226g), UPC 14106-00234.    Refrigerate after opening.  Ingredients:  strawberries, cherries, sugar, pectin.
Wienke's Market Cherry Rhubarb Jam, Net Wt. 8 oz (226g), UPC 14106-00216.  Refrigerate after opening.  Ingredients:  cherries, rhubarb, sugar, pectin.
Wienke's Market Peach Jam, Net Wt. 8 oz (226g), UPC 14106-00224.  Refrigerate after opening.  Ingredients:  peaches, sugar, pectin.
Wienke's Market Blackberry Jam, Net Wt. 8 oz (226g), UPC 14106-00202.  Refrigerate after opening.  Ingredients:  blackberries, sugar, pectin.
Wienke's Market Apple Butter, Net Wt. 8 oz (226g), UPC 14106-00200.  Refrigerate after opening.  Ingredients:  Apples, sugar, cinnamon, cloves, allspice.
Wienke's Market Strawberry Jam, Net Wt. 8 oz (226g), UPC 14106-00231.    Refrigerate after opening.  Ingredients:  strawberries, sugar, pectin.
Wienke's Market No Sugar Added Seedless Strawberry Jam,  Net Wt. 8 oz (226g), UPC 14106-00316.  Refrigerate after opening.  Ingredients:  strawberry puree, rice syrup, grape juice, pectin.
Wienke's Market No Sugar Added Seedless Raspberry Jam,  Net Wt. 8 oz (226g), UPC 14106-00314.  Refrigerate after opening.  Ingredients:  raspberry puree, rice syrup, grape juice, pectin.
Wienke's Market Raspberry Rhubarb Jam, Net Wt. 8 oz (226g), UPC 14106-00229.    Refrigerate after opening.  Ingredients:  raspberries, rhubarb, sugar, pectin.
Wienke's Market Hot Pepper Jam, Net Wt. 8 oz (226g), UPC 14106-00221.  Refrigerate after opening.  Ingredients:  sweet red peppers, onion, hot peppers, sugar, pectin.
Wienke's Market Cherry Blueberry Jam, Net Wt. 8 oz (226g), UPC 14106-00214.  Refrigerate after opening.  Ingredients:  cherries, blueberries, sugar, pectin.
Wienke's Market Black Raspberry Jam, Net Wt. 8 oz (226g), UPC 14106-00203.  Refrigerate after opening.  Ingredients:  black raspberries, sugar, pectin.
Wienke's Market Apricot Jam, Net Wt. 8 oz (226g), UPC 14106-00201.  Refrigerate after opening.  Ingredients:  Apricots, sugar, pectin.
Wienke's Market Hot Raspberry Jam, Net Wt. 8 oz (226g), UPC 14106-00240.    Refrigerate after opening.  Ingredients:  raspberries, sweet red peppers, onion, hot peppers, sugar, pectin.
Wienke's Market No Sugar Added Apple Butter,  Net Wt. 8 oz (226g), UPC 14106-00300.  Refrigerate after opening.  Ingredients:  apples, cinnamon, cloves, allspice.
Wienke's Market No Sugar Added Cherry Rhubarb Jam,  Net Wt. 8 oz (226g), UPC 14106-00309.  Refrigerate after opening.  Ingredients:  cherries, rhubarb, rice syrup, grape juice, pectin.
Wienke's Market Plum Jam, Net Wt. 8 oz (226g), UPC 14106-00226.  Refrigerate after opening.  Ingredients:  plums, sugar, pectin.
Wienke's Market No Sugar Added Strawberry Rhubarb Jam,  Net Wt. 8 oz (226g), UPC 14106-00319.  Refrigerate after opening.  Ingredients:  strawberries, rhubarb, rice syrup, grape juice, pectin.
Wienke's Market Blueberry Rhubarb Jam, Net Wt. 8 oz (226g), UPC 14106-00207.  Refrigerate after opening.  Ingredients:  blueberries, rhubarb, sugar, pectin.
Wienke's Market No Sugar Added Summer Blend Jam,  Net Wt. 8 oz (226g), UPC 14106-00320.  Refrigerate after opening.  Ingredients:  cherries, strawberries, blackberries, blueberries, raspberries,  rice syrup, grape juice, pectin.
Wienke's Market Blueberry Jam, Net Wt. 8 oz (226g), UPC 14106-00205.  Refrigerate after opening.  Ingredients:  blueberries, sugar, pectin.
Wienke's Market No Sugar Added Strawberry Jam,  Net Wt. 8 oz (226g), UPC 14106-00315.  Refrigerate after opening.  Ingredients:  strawberries, rice syrup, grape juice, pectin.
Wienke's Market No Sugar Added Blueberry Jam,  Net Wt. 8 oz (226g), UPC 14106-00303.  Refrigerate after opening.  Ingredients:  blueberries, rice syrup, grape juice, pectin.
Wienke's Market No Sugar Added Blackberry Jam,  Net Wt. 8 oz (226g), UPC 14106-00302.  Refrigerate after opening.  Ingredients:  blackberries, rice syrup, grape juice, pectin.
Simply Delicious, Inc. dba Bobo's Oat Bars
Nationwide distribution.  No govt/VA/military or foreign consignees.
Bobo's Coconut Oat Bar   3oz.  Packaged in overwrap film per single bar
Bobo's recalled Coconut 3oz Bar due to mold.
US Distribution to the states of : VA, NJ, MI, GA, and Internationally to  France
Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms)    The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.
Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.
Product was distributed U.S.A. nationwide.
Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg  and 1800 mg glass vials, Manufactured by: Shandong Luye Pharmaceutical Co, Ltd, Yantai, Shandong. PRC
Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche
Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials
TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials, 10 vials + 10 amps x 4 mL, Manufactured by: Biomedica Foscama Industria, Ferentino, Italy
Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan
Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l.
Laennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp, Korea
Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India
distributed in  AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WY.  International including Netherlands.
Chobani Flip Key Lime Crumble - Key Lime Low-Fat Greek Yogurt with Graham Crackers & White Chocolate, 4-packs, 4/5.3 oz cups are packaged with a cardboard overwrap.  The net wt. of each single serve up is 5.3 oz. and the net wt. of 4-pack is 21.2 oz.  The 4-pack overwrap label has the UPC 8 18290 01484 9 and single serve cup has the UPC 8 18290-01227 2.
while the ingredients statement and the Contains statements on both the overwrap label and the flip label on each individual cup declare wheat.
Expiration dates or best-by dates:    JAN 27 18    FEB 03 18     FEB 08 18     FEB 09 18     FEB 18 18     FEB 19 18     FEB 27 18     MAR 03 18      Plant code line number: 16-012 170
distributed in AK, AR, AZ, CA, CO , FL, GA, IA, IL, IN, KY, MI, NC, NE, NH, NJ, NS, NV, NY, OH, OR, PA, SC, TX, UT, VA, VT, WA, WI, and WY.
Prickly Ash Bark Powder is recalled due to a potential contamination with Salmonella.
One domestic and 1 foreign consignee ( Spain)
Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system
One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.
Mindray DS USA, Inc. dba Mindray North America
Distributed in 26 states: AL, CA, CO, FL, GA, IA, IN, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, PA, SD, TX, UT, WA, and WY; and Puerto Rico.
TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate.
All battery chargers with part number 115-030108-00
Worldwide Distribution - US Nationwide in the U.S. States: of AK, AZ, CA, CO, FL, GA, IL, KY, LA, MD, MA, MI, MN, MT, MO, NJ, NY, NC, OH, PA, RI, TN, TX, UT, VA, WA, and WV;  and the countries of Argentina, Australia, Austria, Belgium, Canada, Egypt, France, Germany, India, Italy, Japan, Kazakhstan, Lithuania, Netherlands, Saudi Arabia, Spain, Switzerland, United Arab Emirates, and Uzbekistan.
AIRO Mobile CT System, Model Number: MobiCT-32    Product Usage:  The AIRO is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 107cm aperture excluding pediatric patients and patients weighing over 400 lbs. (182 kg).
Risk of unintended motion while the AIRO system is in transport mode.
distributed in CA, CO, CT, FL, GA, IA, IN, NH, NY, PA, SC, TX, WA, and WI.
Bulletproof Collagen Protein is recalled due to undeclared milk.  The actual product inside the package is whey (milk) protein but mis-labeled as collagen protein.
Lot #1017088 EXP03/19.  EXP03/19 means expires by March 2019.
Apheresis product, in which quality control for residual WBC count was not performed, was distributed.
ELWOOD FAT-FREE LOW SODIUM RANCH DRESSING ARTIFICIAL FLAVOR. Single serve.
The firm does not have a scheduled process on file for this product.
AArtis Q/ Q.Zen biplane  Artis zee biplane  Product Usage: Artis 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.
Within a specific number of Artis zee biplane and Artis Q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to quality standards. A quality inspection will be initiated to ensure all screws in the rotation unit meet quality standards.
Beef Mix H1.0, a pelleted feed supplement medicated with Melengestrol Acetate (MGA) to control estrus (heat) in feedlot heifers, was recalled because MGA assay results are found to be sub-par.
Code: 6250080317m619840.    6520 is product code, 080317 is date code, and m619840is  lot code.
Nationwide. Product was sold at Panera Cafes.
Panera Plain Cream Cheese, 2 oz. and 8 oz.
Product may be contaminated with Listeria monocytogenes.
Panera Chive&Onion Reduced Fat Cream Cheese Spread, 2 oz. and 8 oz.
Reduced-Fat Wild Blueberry Cream Cheese, 2 oz. and 8 oz.
Panera Reduced-Fat Honey Walnut Cream Cheese, 2 oz. and 8 oz.
Panera Reduced-Fat Plain Cream Cheese, 2 oz. and 8 oz.
Nationwide including US Virgin Island and Puerto Rico; Non US:    1. Singapore  2. Bahamas  3. United Kingdom  4. Ireland  5. Canada
Blood bank software, with a defect or glitch, was distributed.
Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51
Subpotent Drug: Out of specification for assay (stability testing)
Distributed nationwide within the United States
Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72),  Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3198-54.
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72),  Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3213-54.
Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72),  Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3214-54.
Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72),  Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3212-54.
PowerPICC Provena Catheters, as 3 Fr. Single lumen and 4 Fr. Dual Lumen.  Packaged in a poly tray with Tyvek lid within a header bag configuration or a breather bag configuration.
Possible leaks on the 3 Fr. Single lumen and 4 Fr. Dual lumen PowerPICC catheters at the luer hub extension leg junction.
DON BOCARTE ARTE EN EL PALADAR MIGAS BONITO DEL NORTE PESCA SELECTA DEL CANTABRICO; UPC: 8 43700227144
Product may have elevated levels of Scombrotoxin (histamine).
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm, Material CA30L1
The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm, Material CA15L1
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 15cm (reinforced), Material CA15L2
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm, Material CA20L1
Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 30cm (reinforced), Material CA30L2
Blood products collected from a donor for whom donor suitability was not adequately determined, were distributed.
Distributed nationwide. They estimate 4% of the product may be recovered.
VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, SUBCUTANEOUS INJECTION ONLY add 1.4 mL 0.9% Sodium Chloride to make 2.5 mg/ mL final concentration, INTRAVENOUS INJECTION ONLY add 3.5 mL Sodium Chloride to 1 mg/mL final concentration, Rx Only, Distributed by MILLENNIUM Pharmaceuticals, Inc., Cambridge, MA 02139-4234, NDC 63020-0049-01
Defective Container: Confirmed reports of loose vial crimps.
Precedence 16 Model # 882350    Product Usage:  Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.
Philips has identified an issue during collimator exchange that may result in the collimator falling from the detector head or collimator cart.  There may be times when the alignment of the collimator cart and detectors are such that a collimator exchange fails, and fails in such a way  that a collimator drops to the floor beside the collimator cart. In some cases, the collimator may be partially supported by the cart (e.g. leaning against the cart), and in others it may fall/slide all the way to the floor.
BrightView  Model 882480    Product Usage:  BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).
Precedence 6 Model # 882351    Product Usage:  Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.
BrightView XCT Model 882482    Product Usage:  BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with an x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and BrightView XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The BrightView XCT imaging system should only be used by trained healthcare professionals.
BrightView X, Model #882478     Product Usage:  BrightView and BrightView X are gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomography (ECT) studies. The cameras can be used to perform planar static, dynamic, gated, and total body studies, as well as circular-orbit and noncircular orbit SPECT studies, gated SPECT (circular and noncircular)studies, computer-programmed protocol strings, and reference scans (dual detectors only).
AK, AL, AR,  CO, FL, GA, IA, ID, IL, IN, KS, KY,LA, MD, ME, MI, MN, MO,MS, MT, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TX, VT, WA, WI
SunGlow, European Style Butter Blend Margarine, packaged in the following configurations:    1.  16842 SNG, Net Wt 16 oz (1 lb) 454 g.  Keep Refrigerated.  UPC 26700-13410.  Outer case:  Net Wt 36 lb (16.32 kg).  UPC 1 00 26700 13410 1  Ventura Foods, Brea, CA  92821     2.  16836 SNG,  5 grams, Keep Refrigerated.  Outer Case:  Net Wt 7.9 lb (3.6kg), UPC 1 00 26700 13405 7 Ventura Foods, Brea, CA  92831
SunGlow contains undeclared soy lecithin.
SunGlow, Unsalted European Style Butter Blend Margarine (16953 SNG), Net Wt 16 oz (1 lb) 454 g.  Keep Refrigerated.  UPC 26700-13499.  Outer case:  Net Wt 36 lb (16.32 kg).  UPC 1 00 26700 13499 6.  Ventura Foods, Brea, CA  92821
United States, Kuwait, Panama, Malaysia, Vietnam, Chile, Colombia, Egypt, China, Australia, Ecuador, Guatemala, Argentina, South Africa, India, Belgium, Mongolia, Peru, Brazil, Jordan, Pakistan, Taiwan, Thailand, United Arab Emirates, Korea, Israel, Singapore, Mexico, Canada
LIFECODES HLA-A SSO Typing Kit (that utilize MATCHIT! DNA Software v1.2);  Product No. 628911
Immucor GTI Diagnostics' LIFECODES HLA-A SSO Typing Kits and LIFECODES HLA-A eRES SSO Typing Kits that utilize MATCH IT! DNA Software v1.2, were distributed.
MATCHIT! DNA Software, an accessory to Immucor GTI Diagnostics, Inc's     LIFECODES HLA-A SSO Typing Kit:  Product Number 628911:  Lots - 02017A, 06206B, 3006227;
LIFECODES HLA-A  eRES SSO Typing Kit (that utilize MATCHIT! DNA Software v1.2); Product No. 628913
MATCHIT! DNA Software, an accessory to Immucor GTI Diagnostics, Inc's     LIFECODES HLA-A eRES SSO Typing Kit:    Product Number 628913:  Lots -  02017B, 06206C, 12076X
CA, NV, WA, OR, UT, AK, AZ, TX, OK, OH, MO, KY, MI, WI, NE, IL. IN, KS, NY, CT, NJ, PA, MA, MD, DE, DC, VA, HI.
Daisho Kimchi Hot Pot Soup Base; 1.60 lb pouch (10 units per case)    Bar Code: 49 04621 04221 9    Product of Japan  Imported by JFC International Inc., Los Angeles, CA.
Daisho Kimchi Hot Pot Soup base contains undeclared fish - shrimp and crab.
TX, AZ, VT, RI - Samples to CA, MN, NC, RI, NY,TX
Olde Thompson Sweet & Smoky BBQ  Grinder  NET WT. 6.7 oz. (189.9g)    Olde Thompson  Oxnard, CA    Ingredients: Sea Salt, demerara sugar, Dehydrated garlic, chili pepper, mustard seed, paprika, black pepper, oregano, coriander seed, cumin seed, natural hickory smoke flavor, thyme, extractives of paprika:    Serving size 1/4 tsp  Nutrition Facts:  Total Fat 0 g  Sodium 0 g  Total Carb 1 g  Protein 0 g
The seasoning mix Nutrition label states that the sodium content is 0 mg, when it actually contains 350 mg of salt per serving.
Lot Number: OT 1688  Best Before: 11/2018;  Lot Number: OT 2013  Best Before: 12/2018;  Lot Number: OT 1687  Best Before: 1/2019;  Lot Number: OT 3329  Best Before: 3/2019.