Firm is recalling one lot of baby broccoli because it may be contaminated with bacteria contained in dripping ice water from a drain tray in the cooler.

FDA Dec 25, 2019

VEGETABLES STIR FRY served on the hot bar

Possible contamination with Listeria monocytogenes

FDA Dec 25, 2019

SLAW COCONUT CITRUS served on the salad bar

Possible contamination with Listeria monocytogenes

FDA Dec 25, 2019

CAULIFLOWER BROCCOLI ETHIOPIAN served on the hot bar

Possible contamination with Listeria monocytogenes

FDA Dec 25, 2019

Cauliflower Caulilini sold on the salad bar

Possible contamination with Listeria monocytogenes

FDA Dec 25, 2019

Trend Alert Caulilini with Vadouvan Curry served on the salad bar

Possible contamination with Listeria monocytogenes

FDA Dec 25, 2019

BROCCOLI GARLIC SUNDRIED TOMATOES and served on the salad bar

Possible contamination with Listeria monocytogenes

FDA Dec 25, 2019

Freshness Guaranteed Croissants in clear plastic 12oz clamshell, 12 clamshells per case, item number 7012

Product is missing ingredient and nutrition label on bottom of clamshell retail package. Missing ingredients include allergens MILK, WHEAT, and SOY

FDA Dec 25, 2019

Chicken Cashew sold on the hot bar and in chef's case

Possible contamination with Listeria monocytogenes

FDA Dec 25, 2019

Caulilini, Roasted sold on the salad bar

Possible contamination with Listeria monocytogenes

FDA Dec 25, 2019

Bulgogi Beef with Vegetables sold on the hot bar

Possible contamination with Listeria monocytogenes

FDA Dec 25, 2019

Hodgson Mill Unbleached All-Purpose White Wheat Flour 5 Lb bags 001042 Best By 10-01-2020 005517 Best By 10-02-2020

Flour may be contaminated with STEC E, coli

FDA Dec 25, 2019

SALAD BROCCOLI KALE served on the hot bar

Possible contamination with Listeria monocytogenes

FDA Dec 25, 2019

Salmon Dinner with Lemon Herb for 2 packaged in the store UPC 20451100000

Possible contamination with Listeria monocytogenes

FDA Dec 25, 2019

Vegetable eggroll 2 oz. and 3 oz.

Produced and packaged under insanitary conditions

FDA Dec 25, 2019

Wedge Charred Corn Salad served on the salad bar

Possible contamination with Listeria monocytogenes

FDA Dec 25, 2019

Siracha HOT Chili Sauce Net Wt. 28 oz. (1 lb. 12 oz.) (793 g); Net Wt. 17 oz. (1 Lb. 1 oz.) in PET Plastic bottles UPC: 0 24463 06116 Huy Fong Foods, Inc. 4800 Azusa Rd. Irwindale, CA 91706

Firm received complaint of Siracha sauce bulging at top seal and exploding upon removing seal

FDA Dec 25, 2019

SLAW CARROT GINGER served on the hot bar

Possible contamination with Listeria monocytogenes

FDA Dec 25, 2019

Single meal Chicken Rosemary Paleo UPC 232361000003 sold in the chef's case, PLU 32361

Possible contamination with Listeria monocytogenes

FDA Dec 25, 2019

Slaw, Brussels Sprouts with Apples & Cheddar served on the salad bar

Possible contamination with Listeria monocytogenes

FDA Dec 25, 2019

Chicken Orange Sesame sold on the hot bar

Possible contamination with Listeria monocytogenes

FDA Dec 23, 2019

Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature, NIBP and CO2, and for the evaluation of resting ECG, arrhythmias, ST-segments and cardiac output. Some systems are built and designed to measure End Tidal CO2. The system is intended for use in hospital cardiac catheterizati

The application may crash during the cath lab procedure.

Merge sent an Important Alert letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with questions were instructed to contact Merge Support at 866-261-5761 or support@merge.com. For questions regarding this recall call 877-741-5369.

FDA Dec 23, 2019

Lamicel 20PK 3MM INTL Cervical dilator

Routine sterilization dose does not meet the required Sterility Assurance Level.

Medtronic will send the Consignee Notification and Customer Confirmation Form (or equivalent record) to each listed consignee. Consignees will be asked to confirm receipt of FCA notification.

FDA Dec 20, 2019

TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is provided to the patient, depending on the therapy objective.

The action is being initiated due to potential installation of faulty peltier-elements within the thermo-regulation system. Failure of the peltier-element would report a system failure and no longer be able to guarantee temperature control at full power.

FDA Dec 20, 2019

S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a self-expanding stent made of Nitinol (nickel-titanium alloy) material and a 6 French (2.0 mm) or 7 French (2.3 mm) sheathed delivery system. The stent is laser cut from a solid nitinol tube into a fine mesh ( Z Configuration) design. The stent expands to its unconstrained diameter when released from the deployment catheter into the iliac artery. Upon deployment, the stent for

Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".

Customers were notified with a Medical Device Correction letter. The letter was sent via overnight delivery beginning 11/14/2019. The letter identified affected product, provided a description of the problem, and asked that a copy of the letter be retained where the product is stored. Customer were asked to completed and return an Acknowledgement Form. Questions can be directed to the Cordis Endovascular Medical Information Line 877-DEVICE5 (877-338-4235) Monday through Friday 9:00 am - 5:00 pm EST.

FDA Dec 20, 2019

ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinic

When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) version 1 and Central Information Center (CIC) systems were identified to have vulnerabilities to a cyber-attack.

The firm disseminated the notices by mail on 11/12/2019. The letter identified the security vulnerability of certain GE Central Stations and ApexPro Telemetry servers and provided additional best practices, ensuring the following: 1. MC and IX Networks are isolated; 2. MC and IX Router/Firewalls block incoming traffic, as applicable; 3. Restricted physical access to Central Stations, Telemetry Servers, MC network and IX network; 4. Default passwords are changed as applicable; and 5. Password management best practices are adhered to Ensuring the networks are properly configured and isolated protects against these potential concerns and mitigates the risk.

FDA Dec 20, 2019

ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human whole blood.

Devices were delivered without the required dry ice.

On about 04/04/2019, Abbott notified customers in Latvia of the recall. Instructions included to examine inventory for any affected devices on hand, review the letter with your Medical Director or Laboratory Management and follow your laboratory protocol regarding the need for reviewing previously reported patient results, complete and return the Customer Reply form, and notify customers if the affected devices have been forwarded to other laboratories and provide them a copy of the notification letter. If replacement material is available, customers were instructed to discontinue the use of affected devices and destroy any remaining inventory according to your laboratory procedures. If replacement material is not available, immediately order replacement material. Abbott instructed customers that they may continue to use the impacted material as long as controls are within range. Destroy impacted material once replacement material is available.

FDA