Recalls for 09/15/2015

Thoratec Issues Voluntary Device Correction
09/15/2015 Food Recall

Thoratec Corporation (NASDAQ: THOR) today issued a voluntary Urgent Medical Device Correction Letter to all hospitals who have patients supported with the HeartMate II LVAS reminding them to monitor the expiration date of the backup battery contained within the HeartMate II “Pocket” System Controller, as specified in the product Instructions for Use. This backup battery has a 36 month expiration date.

  • Company:
    Thoratec Corporation
  • Problem
    Reminder To Hospitals To Check Backup Battery Expiration
Iowa Select Herbs, LLC Issues a Nationwide Recall of Its Products Pursuant to Consent Decree Issued by the Federal Court for the Northern District of Iowa
09/15/2015 Food Recall

Iowa Select Herbs, LLC (the "Company") is conducting a consumer recall for inventory sold between January 1, 2015 and August 17, 2015 pursuant to a Consent Decree issued by the federal court for the Northern District of Iowa. The Consent Decree was issued because the Company manufactured and distributed unapproved new drugs, misbranded drugs, misbranded dietary supplements, and dietary supplements not manufactured in compliance with the current Good Manufacturing Practice regulations for Dietary Supplements, and therefore adulterated.

  • Company:
    Iowa Select Herbs, LLC
  • Problem
    Violation Of Federal Flammability Standards
Potential Health Hazard: Recalled Snack Fresh Brand Red Apple Slices May Have Been Distributed To Florida's Palm Beach County School District
09/15/2015 Food Recall

Appeeling Fruit Inc. in Dauberville, Penn. has been informed by one of its customers that some of the Snack Fresh brand, 2 oz. bagged red apple slices with Best-if-Used-by date 09/21/15 and production date 310815 that was voluntarily recalled on Wednesday, September 9 due to the potential of being contaminated with listeria monocytogenes may have been distributed to schools in Florida’s Palm Beach County School District (product photo is available at www.appeelingfruit.com). Listeria monocytogenes is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

  • Company:
    Appeeling Fruit Inc.
  • Problem
    Listeria Monocytogenes
Clozapine: Drug Safety Communication - FDA Modifies Monitoring for Neutropenia; Approves New Shared REMS Program
09/15/2015 Medical Recall

Enhanced labeling explaining how to monitor patients for neutropenia/manage clozapine treatment. Approval of new, shared REMS.

  • Category
    Schizophrenia
Segway Recalls Off-Board Chargers for Segway Personal Transporters Due to Shock Hazard (Recall Alert)
09/15/2015 Product Recall

A wire inside the charger can detach and touch the side of the charger, posing a shock hazard.

  • Company:
    Segway Inc.
  • Product:
    Off-Board Charger for Segway Personal Transporter (PT)
  • Problem
    Crash Hazard (Recall Alert)
  • Recall Number
    15-754
Segway Recalls Off-Board Chargers for Segway Personal Transporters Due to Shock Hazard (Recall Alert)
09/15/2015 Product Recall

A wire inside the charger can detach and touch the side of the charger, posing a shock hazard.

  • Company:
    Segway Inc.
  • Product:
    Off-Board Charger for Segway Personal Transporter (PT)
  • Problem
    Crash Hazard (Recall Alert)
  • Recall Number
    15-754