The U.S. Food and Drug Administration today permitted marketing of two new devices to assess a patient’s cognitive function immediately after a suspected brain injury or concussion. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices permitted for marketing that are intended to assess cognitive function following a possible concussion. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury.
Honeywell Issues Voluntary Nationwide Recall Of One Lot Of Eyesaline Eyewash Solution Due To Microbial Contamination
In cooperation with the U.S. Food and Drug Administration (FDA), Honeywell is voluntarily recalling one production lot of 32-ounce bottles of Eyesaline Eyewash solution, which is used for emergency eye rinsing after an injury.
Cambridge Farms, LLC Recalls Three Brands Of Frozen Cut Corn Because Of Possible Health Risk
Cambridge Farms, LLC of Lancaster, PA is recalling the below products because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Oriental Packing Co. Inc. Issues Alert On Lead In Curry Powder
Oriental Packing Co., Inc., Miami, Florida is recalling approximately 377,000 lbs. of the following blended seasoning curry products because it is contaminated with lead. Lead can accumulate in the body over time and can cause serious and sometimes permanent adverse health consequences.
Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Oxacillin for Injection, USP, 10g Due to Presence of Iron Oxide Particulate Matter
Sagent Pharmaceuticals, Inc. today announced the voluntary nationwide recall of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp. Date March 2017) manufactured by Astral SteriTech Private Limited and distributed by Sagent.
FDA approves expanded indication for two transcatheter heart valves for patients at intermediate risk for death or complications associated with open-heart surgery
The U.S. Food and Drug Administration today approved an expanded indication for the Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. These devices were previously approved only in patients at high or greater risk for death or complications during surgery.
Voluntary Nationwide Recall of Cetylev® (Acetylcysteine) Effervescent Tablets for Oral Solution Due to an Inadequate Seal of the Blister Pack
Arbor Pharmaceuticals, LLC (Arbor) today announced a voluntary recall of three (3) lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, due to an inadequate seal of the blister pack. An inadequate seal could result in an increase of oxygen and moisture entering the blister cavity which can start the effervescent process. This results in enlarged and swelled tablets which could also completely dissolve within the blister pack.
Bakers of Paris Recalls Croissants Sold at Whole Foods Market® Stores in Northern California Due to Undeclared Allergen
Bakers of Paris (Brisbane California), is recalling plain and chocolate croissants sold in 18 Northern California Whole Foods Market stores due to an undeclared allergen. The croissants, sold individually in self-service cases and in clear plastic packs of four, are made with an egg wash which is not declared on the ingredient list.
Sage Products Expands Voluntary Nationwide Recall of Comfort Shield Barrier Cream Cloths Due to Microbial Contamination
Cary, IL, Sage Products announced today it is expanding its voluntary nationwide recall to include an additional lot of Comfort Shield Barrier Cream Cloths at the distributor and healthcare facility/user level. The recall is being initiated due to product contamination with the bacteria, Burkholderia cepacia.
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.