Thoratec issues UMDC for HeartMate II LVAS [US]

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US/Silver Spring: FDA LogoThoratec Corp. issues an 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 due to injury and death hazards. FDA: http://ht.ly/Sm5gd

Direct link: http://www.fda.gov/Safety/Recalls/ucm462627.htm

Additional information:
This Urgent Medical Device Correction Letter concerns certain HeartMate II LVAS units reminding clinicians to monitor the expiration date of patient backup battery contained within the HeartMate II “Pocket” System Controller, as specified in the product Instructions for Use.

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Iowa Select Herbs Dietary Supplement Recall [US]

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US/Silver Spring: 5849 - IowaSelectHerbsDietarySupplementsIowa Select Herbs recalls for dozens of Dietary Supplements due to the production and distribution of 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, all serious health hazards. FDA: http://ht.ly/SlHLS

Direct link: http://www.fda.gov/Safety/Recalls/ucm462536.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplements are subject to this recall:

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Juratoys Fishing Game Toy Recall [US & Canada]

Canada CFIA RecallUS FlagUS/Washington & Canada/Ottawa: Juratoys Fishing Game Toy Recall [US & Canada]Juratoys recalls approximately 14,200 Sardines Fishing Game and Starfish Fishing Game Toys due to choking and ingestion hazards. CPSC: http://ht.ly/SkrBw; HCSC: http://ht.ly/SkrEP

Direct US link: http://www.cpsc.gov/en/Recalls/2015/Juratoys-Recalls-Fishing-Games/

Direct Canada link: http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2015/54960r-eng.php

Additional information:
The US Consumer Product Safety Commission (“CPSC”) reports this recall involves two (2) models of the Juratoys Fishing Game, Sardines and Starfish.

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Next brand Children’s Robe Recall [UK]

UK FSA RecallUK/Basildon: Next Children's Robe Recall [UK]Next recalls certain Children’s Robes due to failure to meet UK flammability regulations and burn hazards. CTSI: http://ht.ly/SgGOL

Direct link: http://www.tradingstandards.uk/advice/advice-recall-item.cfm?id=313905

Additional information:
The UK Chartered Trading Standards Institute (“CTSI”) reports the following Children’s Robes are subject to this recall:
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Lululemon Athletica Clothing Recall [Australia]

Australia ACCC RecallAustralia/Canberra: Lululemon Athletica Clothing Recall [Australia]Lululemon Athletica recalls numerous Assorted Lululemon Tops due to possible facial, ocular and neck laceration hazards. ACCC: http://ht.ly/SjDrA

Direct link: http://www.recalls.gov.au/content/index.phtml/itemId/1075683

Additional information:
The Australian Competition & Consumer Commission (“ACCC”) reports this recall concerns an elastic draw cord with a hard metal or plastic tip used around the hood/neck area of numerous Lululemon Tops. Each Top displays an embroidered or printed Lululemon logo; the location of the logo varies with the style of the garment.

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