Food and Drug Administration Recall News
Beacon Tip Angiographic Catheters
On October 7, 2015, Cook Medical put out a recall for select sized Beacon Tip Angiographic Catheters, which were found to exhibit tip splitting or separation. 42 Medical Device Reports have been made due to the fact that tip splitting is a defect that has the potential to lead to loss of device function. It may even require medical intervention to retrieve a separated segment. If not retrieved, there is a potential to occlude blood flow to end organs, which means to obstruct the pathway of blood flow.
Product Identification and Information: These specific catheters were distributed globally between September 2012 and September 2015. The identification for the product is located on the outer package product label and the part numbers are those with catalog number prefixes and suffixes listed here:
Specific versions of the Torcon NB® Advantage Beacon®Tip Catheters (catalog prefix HNBR4.0, HNBR4.1 and only HNBR5.0 with the RUC suffix), Royal Flush® Plus Beacon®Tip High-Flow Catheters (catalog prefix HNR4.0), and Slip-Cath® Beacon® Tip Hydrophilic Catheters (catalog prefix SCBR4.0, SCBR4.1, and only SCBR5.0 with the RUC suffix), and Shuttle®Select Slip-Cath® catheters (catalog prefix SCBR4.5)
So what is Cook Medical doing about the recall? They are notifying customers and distributors by recall notification letters. These letters state that all customers/distributors discontinue the use of all potentially affected units and return them to the company as soon as possible for credit. If there are any further questions, consumers are urged to call Cook Medical Relations at 1-800-457-4500 or 1-812-339-2235 Monday through Friday, between 7:30 a.m. and 5:00 p.m.
Skipanon Brand Canned Seafood Products
On October 9, 2015, Skipanon voluntarily recalled all lots and all sizes of all Skipanon brand seafoods canned products due to the fact that they have the potential to be contaminated with Clostridium botulinum (Botulism). This is a bacterium that causes life-threatening illness and even death! Skipanon urges that consumers not use the product, even if it does not look or smell spoiled. The reason why consumers should not use the product is because of the dangers of Botulism. It is a potentially fatal form of food poisoning, which can cause general weakness, dizziness, double-vision, trouble with speaking or swallowing, difficulty in breathing, weakness of muscles, abdominal distension, and even constipation. If you experience these symptoms, it is always essential to seek immediate medical attention.
So far, there have been no reported cases of illness to date. The recall was initiated due to lack of documentation and possible under-processed products. It was discovered during the inspection by the FDA, and the inspection is now ongoing. If you have questions, you may contact Skipanon Brand Seafoods LLC at (503) 861-8277 between the hours of 10:00 am and 5:00 pm, Monday through Friday.
Rhino 7 3000 and Rhino 7 Platinum 3000 Capsules
On October 9, 2015, TF Supplements issued a voluntary nationwide recall of all lots of Rhino 7 3000 and Rhino 7 Platinum 3000 Capsules due to undeclared active pharmaceutical ingredients. The ingredients are an undeclared desmethyl carbondenafil and dapoxetine, which are active ingredients not approved by the FDA and a class of drugs used to treat male erectile dysfunction.
Desmethyl carbondenafil can interact with nitrates found in prescription drugs and inevitably lower blood pressure to dangerous levels, which can lead to fatalities. Dapoxetine is used to treat depression and can increase the risk of suicidal thinking.
TF Supplements is currently working on notifying its customers by email about the recall. Consumers should contact TF Supplements by telephone at 866-620-3586 Monday through Friday. They should also return all products to:
6666 Gulf Freeway
Houston, TX 77087