Cook Medical Issues Global Recall of Roadrunner® UniGlide® Hydrophilic Wire Guides due to raw materials issue

DSM Biomedical B.V., the Netherlands, Cook Medical’s supplier of hydrophilic coating for the Roadrunner® Uniglide® Hydrophilic Wire Guide, recalled certain lots of material due to concerns about a potential contamination by glass particles ranging in size of approximately 4 to 280 µm. Cook received one lot of the affected recalled coating. This prompted Cook Medical to initiate a recall of 8,750 units of the Roadrunner UniGlide Hydrophilic Wire Guides on June 24, 2016.

Cook Medical Issues Global Recall of Roadrunner® UniGlide® Hydrophilic Wire Guides due to raw materials issue

DSM Biomedical B.V., the Netherlands, Cook Medical’s supplier of hydrophilic coating for the Roadrunner® Uniglide® Hydrophilic Wire Guide, recalled certain lots of material due to concerns about a potential contamination by glass particles ranging in size of approximately 4 to 280 µm. Cook received one lot of the affected recalled coating. This prompted Cook Medical to initiate a recall of 8,750 units of the Roadrunner UniGlide Hydrophilic Wire Guides on June 24, 2016.

Ton Shen Health Recalls “DHZC-2 Tablet” Because of Possible Health Risk

Ton Shen Health of Chicago, IL, is recalling its “DHZC-2” Tablets because they have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children. Lead poisoning can happen if a person is exposed to high levels of lead over short period of time.
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Rabbit Creek Products recalls certain flavors of bread, muffin and brownie mixes because of a possible health risk

Rabbit Creek Products of Louisburg, KS is recalling certain flavors of Bread mixes, Muffin mixes and Brownie mixes under the Rabbit Creek Products and other Private label brand names due to the potential presence of Escherichia coli O:121 (E. coli O:121). People usually get sick from E. coli O: 121, also referred to as STEC O:121, 2-8 days (average of 3-4 days) after swallowing the bacteria. Most people develop diarrhea (often bloody) and abdominal cramps.

FDA updates draft guidance on premarket safety notifications for dietary supplement industry

The U.S. Food and Drug Administration today issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers.

PharmaTech LLC Issues Voluntary Nationwide Recall Due to Potential Risk of Product Contamination

PharmaTech, LLC of Davie, FL, is voluntarily recalling all liquid products from October 20, 2015 through July 15, 2016 as a precautionary measure due to a potential risk of product contamination with Burkholderia cepacia.If a product contains B. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life-threatening in the at risk patient population.