CIC Jam Recall [Canada]

Canada FlagCanada/Ottawa:Woodapple Jam Recall [Canada] MTI Groups Inc recalls certain batch/lots of CIC brand Jams due to undeclared sulphites/sulfites as well as non-permitted colours, both serious health hazards. CFIA: http://ht.ly/mwCx2

Direct link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/inspection/2013/34331r-eng.php

Additional information:
The Canadian Food Inspection Agency (“CFIA”) reports the following Jams are subject to this recall: Continue reading

SynchroMed Implantable Infusion System Recall [US]

US FDA RecallUS/Silver Spring: Medtronic issues four medical device notifications concerning its SynchroMed Implantable Infusion System due to operational failure hazards. FDA: http://ht.ly/mvnrH

Direct link: http://www.fda.gov/Safety/Recalls/ucm359069.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports Medtronic’s intrathecal drug delivery systems are used to treat chronic, intractable pain and severe spasticity of cerebral or spinal origin.

According to the FDA, Medtronic issued four notifications to provide doctors and other heath care providers with information to help identify and manage safety issues concerning the SynchroMed Implantable Infusion System. The FDA has classified three of these four notifications as new Class I recalls. The fourth notification is an update to a 2011 action related to pump refill that was previously classified by the FDA as a Class I recall.

The four recalls concern the following:

  • SynchroMed Implantable Infusion Pump Priming Bolus: Medtronic has found that any time the priming bolus is used with a SynchroMed pump, drug mixes with the sterile water or cerebrospinal fluid already in the catheter. This mixing results in the unintended delivery of drug prior to the end of the programmed bolus, as well as dilution of some of the drug remaining in the catheter at the end of the bolus. This can contribute to an increased risk of adverse events involving drug overdose or underdose following an initial system implant or revision.
  • SynchroMed Implantable Infusion Pump Shorting: an electrical short could lead to pump motor stall and a subsequent loss of or reduction in therapy, which can result in the return of underlying symptoms and/or withdrawal symptoms. The SynchroMed II pump is equipped with alarms designed to alert the patient in the event of a motor stall.
  • SC Intrathecal Catheter Product Removal: Medtronic has redesigned its Sutureless Connector (SC) Catheter to reduce the potential for occlusion, which is the blockage or cessation of drug flow due to misalignment at the point where the catheter connects to an implantable pump. As a result, the company has initiated a voluntary removal of unused products manufactured before the catheter design change. To reduce the risk for occlusion, Medtronic strongly recommends that customers discontinue the use of all SC Catheter models 8709SC, 8731SC, 8596SC, 8578 manufactured prior to the design change.
  • SynchroMed Implantable Infusion Pump Refill Procedure Safety Update: Medtronic is distributing a revised Clinician Refill Reference Card with information about the pump refill procedure for the SynchroMed Implantable Infusion System. This is a continuation of a 2011 notification that was previously classified as a Class I recall. The revised reference card reflects new product labeling approved by the FDA to help healthcare professionals reduce the potential for a pocket fill during the SynchroMed pump refill procedure. You can download the card here: http://professional.medtronic.com/pt/neuro/idd/ind/product-advisories/index.htm?cmpid=URL_Neuro_HCP_iddadvisories_-

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Recalls Direct RIN: 2013-2205
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Harmony Chai Tea Recall [US]

US FDA RecallUS/Silver Spring: Harmony Chai recalls some Concentrated Black Spiced Chai Tea and Decaffeinated Rooibos Chai Tea due to incomplete processing, Botulism hazards. FDA: http://ht.ly/mvFb2

Direct link: http://www.fda.gov/Safety/Recalls/ucm359139.htm

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

  • Concentrated Black Spiced Chai bottled in 22 oz (650ml) amber glass; UPC: 0510501311 and 64 oz (1892.7ml) amber glass jugs; UPC: 0510501301
  • Decaffeinated Roobios Chai bottled in 22 oz (624.25 ml) amber glass UPC 9450402431 and 64 oz (1892.7ml) amber glass jugs; UPC: 0510501301

About Botulism:
The US National Institutes of Health (“NIH”) says Botulism is a rare but serious paralytic illness caused by a nerve poison that is produced by the bacterium Clostridium botulinum (C. botulinum). Foodborne Botulism is caused by eating foods that contain the botulism toxin. You can also get Botulism from an infected wound. All forms of Botulism can cause paralysis and be fatal so emergency medical attention is necessary.

Clostridium botulinum bacteria cannot grow in air, so Foodborne Botulism is usually seen only when certain foods are stored or prepared improperly. These typically include the following:

  • Improperly prepared low-acid, home-canned foods (such as asparagus, beets, green beans, mushrooms, peppers);
  • Improperly smoked fish;
  • Improperly prepared raw marine mammal meat (such as whale, walrus, seal);
  • Non-refrigerated storage of low-acid fruit juices (such as carrot juice); and
  • Baked potatoes improperly stored in aluminum foil.

To learn more about Botulism, please visit the US National Institutes of Health (“NIH”): http://1.usa.gov/HLOr3Q

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Recalls Direct RIN: 2013-2204
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NHTSA June Vehicle Recalls – 53 MTD [US]

FlagUSUS/Washington: As of Saturday, June 29, 2013, the US National Highway Traffic Safety Administration has posted 53 vehicle or tire recalls so far this month. Are yours listed? http://ht.ly/5G8bb

Direct link: http://www-odi.nhtsa.dot.gov/owners/SearchCurrentMonthRecall

Additional information:
Recently added recalls include products from the following manufacturers:

  • Chrysler Group LLC – Fuel leakage, fire hazards: potential number of units affected: 1,560,000
  • Chrysler Group LLC – Power train and steering hazards: potential number of units affected: 180,131
  • Chrysler Group LLC – Engine stall hazard: potential number of units affected: 12,907
  • Chrysler Group LLC – Lighting failure hazard: potential number of units affected: 30,197
  • Chrysler Group LLC – Air bag, electrical system, seat belts hazards: potential number of units affected: 254,396
  • Collins Bus Corp. – Fire hazard: potential number of units affected:  17
  • Ford Motor Company – Fuel system hazards: potential number of units affected: 390,783
  • Forest River, Inc. – Smoke, melting or fire hazards: potential number of units affected: 289
  • General Motors LLC – Fuel system hazards: potential number of units affected: 1,791
  • General Motors LLC – Electrical short circuit hazard: potential number of units affected: 193,652
  • GITI Tire (USA) – Air loss, crash hazards: potential number of units affected: 218
  • Honda (American Honda Motor Co.) – Braking impairment hazard: potential number of units affected: 18,352
  • Honda (American Honda Motor Co.) – Fire, smoke hazards: potential number of units affected: 143,083
  • Mitsubishi Motors North America, Inc. – Glass roof detachment hazard: potential number of units affected: 3,181
  • North American Bus Industries, Inc. – Fire hazard: potential number of units affected: 100
  • Ohlins Racing AB – Steering failure, crash, injury hazards: potential number of units affected: 801
  • PACCAR Incorporated – Electrical system hazards: potential number of units affected: 1,340
  • PACCAR – Crash hazard: potential number of units affected: 4
  • PACCAR – Slip and fall hazards: potential number of units affected: 19
  • Sutrak USA – Fire hazard: potential number of units affected: 154
  • Tesla Motors, Inc – Injury hazard: potential number of units affected: 1,228
  • Toyota Motor Engineering & Manufacturing – Brake impairment hazard: potential number of units affected: 87,060
  • Vermeer Manufacturing Company – Brake impairment, crash hazards: potential number of units affected: 14
  • Zero Motorcycles Inc – Burn hazard: potential number of units affected: 128

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Recalls Direct RIN: 2013-2203
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Ford Explorer, MKS, Taurus Recall [Canada]

Transport Canada RecallCanada/Ottawa: Ford recalls some Explorer, MKS and Taurus models due to child lock failure, injury hazards. TC: http://ht.ly/muYqy

Direct link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/tc/2013/34351r-eng.php

Additional information:
Transport Canada (“TC”) reports on certain Ford vehicles, the Child Safety lock actuation cam may have been manufactured incorrectly. As a result, the Child Lock may inadvertently disengage, which could allow the rear door to be opened using the inside door handle, possibly resulting in injury.

According to Transport Canada, the following Ford vehicles are subject to this recall:

  • Ford Taurus vehicles; model year: 2013
  • Ford Explorer vehicles; model year: 2013
  • Lincoln MKS vehicles; model year: 2013

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TC ID number: 2013219
Manufacturers recall number: 13S07
Recalls Direct RIN: 2013-2202
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KBC Harley-Davidson Motorcycle Helmet Recall [Canada]

Canada HCSC RecallCanada/Ottawa: KBC Harley-Davidson recalls some Hybrid Classic Cruiser Half Motorcycle Helmets due to operational failure, injury hazards. HCSC: http://ht.ly/muk4d

Direct link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34337r-eng.php

Additional information:
Health Canada/Santé Canada (“HCSC”) reports this recall involves some Harley-Davidson Hybrid Classic Cruiser Half Motorcycle Helmets, part numbers are 98336-09VM/000L, 98336-09VM/002L and 98336-09VM/022L. The recalled Helmets come in black with black interior padding. The Helmet covers the top of the head and ends over the ears. It has a small visor and a Harley-Davidson logo on both sides above the ear. The affected products were manufactured in March 2011.KBC Harley Davidson Helmet

The recalled helmets were sold in Large, X-Large and 2X-Large can be identified by the GM code GM00032205 or have a manufactured date label of XX Mar 2011, located on the helmet’s interior shell under the snap-in liner.

According to Health Canada, KBC America, Inc. was advised by the US National Highway Traffic Safety Administration (“NHTSA”) that four Harley-Davidson Hybrid C/C Half Motorcycle Helmets, size Large, were tested as part of its ongoing Motorcycle Helmet Compliance Program. It was determined that one helmet (“Helmet A”) was non-compliant with S5.2 of the United States Federal Motor Vehicle Safety Standards (FMVSS) 218; one helmet (“Helmet B”) was non-compliance with S5.1 of FMVSS 218; and one helmet (“Helmet C”) was non-compliant with S5.1 and S5.2 of FMVSS 218.

By wearing a non-compliant helmet, the rider may not be adequately protected in the event of a crash, increasing the risk of personal injury.

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HCSC ID number: RA-34337
Recalls Direct RIN: 2013-2201
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Tern Folding Bicycle Recall [US]

US CPSC RecallUS/Washington: 2200 - StileTernFoldingBikeStile Products recalls some Tern Folding Bicycles due to fall, injury hazards. CPSC: http://ht.ly/mtWzZ

Direct link: http://www.cpsc.gov/en/Recalls/2013/Stile-Products-Recalls-Tern-Folding-Bicycles/

Additional information:
The US Consumer Product Safety Commission (“CPSC”) reports this recall involves some Eclipse S11i and Verge S11i, X10, X20 and X30h models of Tern brand Folding Bikes. Continue reading

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