Daily Archives: April 10, 2017

Medtronic Announces Voluntary Worldwide Recall of its Stratamr Adjustable Valves and Shunts

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DUBLIN – Medtronic plc today announced that on February 22, 2017 it notified customers of a voluntary recall of all unused units of the StrataMR™ adjustable valves and shunts. These products are manufactured and marketed by Medtronic’s Neurosurgery business, which is part of the Brain Therapies division of the company’s Restorative Therapies Group. This recall only applies to StrataMR adjustable valves and shunts and does not apply to Strata™ II or Strata™ NSC products.

As of the initiation of this recall, 2,622 StrataMR valves and shunts potentially affected by this recall had been distributed worldwide. The affected StrataMR valves and shunts were manufactured from October 27, 2015 to November 11, 2016. Medtronic initiated the recall due to an increase in the product complaint rate. As of April 1, 2017, the product complaint rate related to this issue was 2.75 percent of total units distributed.Medtronic StrataMR adjustable valves and shunts are used in the management of hydrocephalus. They control the flow of cerebrospinal fluid being drained from the brain to relieve intracranial pressure. Medtronic is conducting this voluntary recall due to an issue that can occur post-implantation that can lead to the potential for under-drainage of cerebrospinal fluid.

Under-drainage of cerebrospinal fluid may result in the following adverse health consequences: headaches, nausea, vomiting and lethargy.

  • If any of the affected products have been implanted in patients, physicians should refer to the StrataMR customer recall letter sent February 22, 2017 as well as the valve adjustment instructions in the instructions for use (IFU) for continued patient care.
  • Patients and their caregivers should monitor the patient’s condition and if they find they are experiencing any of the above-mentioned symptoms, they should consult the physician who implanted the StrataMR valve.

If left untreated, under-drainage can potentially lead to coma and death. There has been one reported patient death, but the cause of death has not been confirmed to be related to this issue.

Medtronic initiated customer communication of the recall by letter and is requesting that customers cease use of all affected product that remains in inventory and return all unused units to Medtronic. The U.S. Food and Drug Administration (FDA) and other regulatory bodies also have been notified.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax.

Precautionary Recall of a Limited Quantity of Organic Marketside Spring Mix Salad is Announced by Fresh Express

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Orlando, Fla. – Fresh Express is announcing a precautionary recall of a limited number of cases of Organic Marketside Spring Mix.

The item subject to the recall is 5 oz. Organic Marketside Spring Mix marketed in a clear container with production code G089B19 and best-if-used-by date of APR 14, 2017 located on the front label, and UPC code 6 8113132897 5 located on the bottom of the container. The recalled salads were distributed only to Walmart stores located in the Southeastern region of the United States.

The recall was necessitated when Fresh Express was notified that extraneous animal matter was allegedly found in a single container of the salad. Out of an abundance of caution, all salads manufactured in the same production run are being recalled.

No other Marketside salads are included in the recall. Fresh Express salads are not subject to a recall.

Walmart acted quickly to remove the product from store shelves.

Consumers who may have already purchased the recalled product should discard and not consume it. A full refund is available where purchased or by calling the Fresh Express Consumer Response Center toll-free at (800) 242-5472 during the hours of 8 a.m. to 7 p.m. Eastern Time.

Upon receiving notification, both Walmart and Fresh Express food safety and rapid response teams, in close coordination with regulatory authorities, acted immediately to review all relevant records, launch an intensive investigation and initiate product removal and recall procedures.

Fresh Express takes matters of food safety very seriously and rigorously complies with all food safety regulations including the proscribed Good Agricultural Practices. In addition, a range of stringent controls are in place during growing and harvesting to mitigate against field material from entering the raw product system. In manufacturing, additional controls including thorough washing and filtration systems as well as visual inspections that are designed to eliminate unwanted debris.

Recalled Product Details

  • Organic Marketside Spring Mix – 5 oz. clear container
  • Production Code of G089B19 and best-if-used-by date of APR 14 2017, located on the top label
  • UPC Code of 6 8113132897 5 located on the bottom of the container next to the bar code

Recalled Product Distribution

Fresh Express Precautionary Recall, 5 oz. Organic Marketside Spring Mix
(No other Marketside Salads and No Fresh Express Salads are included in this recall)

Brand PRODUCT NAME SIZE UPC PRODUCTION CODE BEST IF USED BY DATE POSSIBLE DISTRIBUTION STATES
Marketside Organic Spring Mix 5 oz. 6 8113132897 5 G089B19 APR 14 2017 AL, FL, GA, LA, MS, NC, SC, VA,