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Noble Crust, 8300 4th St N, St. Petersburg, FL 33702, USA
Latest report: June 22, 2020 12:00 PM
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Recent Interesting Reports
Oscor Inc. is voluntarily recalling 14 lots of Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 down to the user level. The Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 have been found to have increased risk of the hub cap and seal... See More on the proximal end of the device handle detaching during use.
RISK STATEMENT: The Destino Twist 14T Model DST1405525 & Guidestar 14F Model D141103 detachment of the hub cap and seal could lead to bleeding at the proximal end of the device and/or air embolism for the patient during intracardiac, renal or other peripheral placements procedures.
Oscor Inc. has reported two (2) Medical Device Reports to the FDA related to detachment of hub cap and seal on the proximal end of the device handle. The recall is limited to the two model numbers and lot numbers outlined above. There are no other recalls associated with this product.
PRODUCT INFORMATION: The product is steerable guiding sheath intended for the introduction of diagnostic and therapeutic devices into the human vascular, including but not limited to intracardiac, renal or other peripheral placements; it cannot be use for neural placements. The product is provided sterile, one unit per pouch / tray for details and can be identified on the printed labeling with the information below (1, 2, and 3).
The affected Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 were distributed Worldwide to distributors and hospitals from June 8, 2021 to November 30, 2021.
Recalled Product Impacted (1)
- Destino Twist 14F (DST1405525). UDI Number: 885672011123. Lot Number: PQOC13475. Expiration Date 10-01-2021. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14073. Expiration Date 11-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14072. Expiration Date 10-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP14071. Expiration Date 10-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13834. Expiration Date 09-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13828. Expiration Date 09-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: DP13827. Expiration Date 08-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12995. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12632. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12633. Expiration Date 07-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12345. Expiration Date 06-01-2024. Packaging State Type: Sterile.
- Guidestar 14F (D141103). UDI Number: 885692010911. Lot Number: PQOC12330. Expiration Date 06-01-2025. Packaging State Type: Sterile.
Destino 14F Twist Model (2)
Product: Destino Twist 14F
GTIN (Unit): 00885672011123
Model: DST1405525
Sheath & Dilator: S55CM D73CM
French Size: 14F
Quantity: 6 Units
Guidestar 14F - Model (3)
Product: Guidestar 14F
GTIN (Unit): 00885672010911
Model: D141103
Sheath & Dilator: S71CM D89CM
French Size: 14F
Quantity: 543 Units
Company name: Oscor Inc.
Brand name: Oscor
Recalled: Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 steerable guiding sheath
Reason of the recall: Hub cap and seal on the proximal end of the device handle may detach during use
FDA Recall date: January 12, 2022
Check the full recall details on fda.gov
Source: FDA See Less
109
I bought these as a special gift for my little Maltese cross. Last night I gave her one. This morning I gave her another one. She’s been non stop puking, trying to poo.
Very uncomfortable.
The only thing different in her diet was introducing these treats.
When... See More I pulled the treats out to read the label today after seeing her like this. She had no interest in the treats. Like she is aware that this is what’s hurting her.
I bought them at the superstore location on Hardin street in Fort Mcmurray Alberta.
After researching them. I feel like they need to be pulled from shelves.
If someone can go to jail for kicking a dog a store and a product owner should also be charged with hurting and animal.
I hope my dog will be okay. And I had kept my bag as evidence in a area closed off to public or any animal.
Thank you. | Symptoms: Vomiting See Less
12
ET
ethelt9
I only give my dog fresh fried fish, scrap stuff, I fry myself and when I make meat for my family I also make meat for my dog, I have never understood why we should even buy prepackaged treat's for our fur babies, besides it's more expensive and got lots of fillers that have nothing to do with carnivore eating mammals. I hope you get to the bottom of what caused your baby to fall ill after consuming those treats.
Woody’s Pet Food Deli Raw Cornish Hen pet food - recalled due to Salmonella, St Paul, MN, USA
3 weeks ago
Woody’s Pet Food Deli is recalling Raw Cornish Hen pet food “With Supplements” sticker due to a Salmonella health risk. The product was distributed in the company’s retail stores in Minneapolis, Saint Paul, and Woodbury, Minnesota.
Salmonella can affect animals eating the product and there is risk... See More to humans from handling contaminated products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
- Woody’s Pet Food Deli RAW CORNISH HEN with SUPPLEMENTS (5 lb. plastic tub). PLU Code 5230. Expiration date 11/20/22
- Woody’s Pet Food Deli RAW CORNISH HEN with SUPPLEMENTS (15 oz. plastic container). PLU Code 1652. Expiration date 11/20/22
Two (2) 5lb tubs were sold in the company’s St Paul store. Twelve (12) 15oz containers were distributed through its 3 Twin Cities, MN retail stores.
Healthy people infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping, and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms.
Consumers exhibiting these signs after having contact with this product should contact their healthcare providers. Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.
The company continues their investigation as to the source of the problem and will resume production when the problem is resolved. The recall is a result of FDA sampling due to a consumer complaint on another product, which testing revealed a sample of this product contains Salmonella.
Consumers who have these products should discontinue use and may return the unused portion to the place of purchase for a full refund. If you have recalled product in your home, clean refrigerators/freezers where the product was stored and clean and disinfect all bowls, utensils, food prep surfaces, pet bedding, toys, floors, and any other surfaces that the food or pet may have had contact with. Because animals can shed the bacteria in the feces when they have bowel movements, it’s particularly important to clean up the animal’s feces in yards or parks where people or other animals may become exposed, in addition to cleaning items in the home. Consumers should thoroughly wash their hands after handling the affected product or cleaning up potentially contaminated items and surfaces.
Company name: Woody’s Pet Food Deli
Brand name: Woody's Pet Food Deli
Product recalled: Raw Cornish Hen pet food “With Supplements”
Reason of the recall: Potential Salmonella
FDA Recall date: December 23, 2021
Check the full recall details on fda.gov
Source: FDA See Less
1.5K
Padagis US LLC announced today it has issued a voluntary nationwide recall to the consumer/user level of the lots of Nitroglycerin Lingual Spray listed in the table below. Out of an abundance of caution, this product is being recalled from the market due to a complaint received... See More that a unit may not dispense.
There is a risk that the product may not properly dispense medication to patients in the event of a malfunction of their dispensing unit. This recall applies only to the 12g spray bottle and not the 4.9g spray bottle of this medication.
- Drug: Nitroglycerin Lingual Spray
- NDC: 45802-210-02
- Strength: 400 mcg per spray
- Net Contents: 12g
- Lot # 150892
- Expiration: Oct 2022
- Drug: Nitroglycerin Lingual Spray
- NDC: 45802-210-02
- Strength: 400 mcg per spray
- Net Contents: 12g
- Lot # 153199
- Expiration: Feb 2023
- Drug: Nitroglycerin Lingual Spray
- NDC: 45802-210-02
- Strength: 400 mcg per spray
- Net Contents: 12g
- Lot # 156041
- Expiration: Apr 2023
Company name: Padagis
Brand name: Perrigo
Product recalled: Nitroglycerin Lingual Spray
Reason of the recall: Unit may not properly dispense medication.
FDA Recall date: December 27, 2021
If the product does not deliver the appropriate amount of nitroglycerin, the patient will likely continue to experience chest pain. The label advises that if relief is not obtained after 3 doses over 15 minutes the patient should promptly seek medical attention. To date, Padagis has not received any reports of adverse events related to this recall.
Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of chest pain due to coronary artery disease in adult patients. All packaging and branding on affected units is that of Perrigo Company PLC. The product is packaged in a 12 g bottle contained within a carton. The medication was distributed Nationwide in the USA to wholesalers and retailers.
Healthcare providers, distributors, and retailers that have product which is being recalled should stop distribution. Patients who have this product should contact their healthcare provider for an alternate replacement before returning the recalled product.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Check the full recall details on fda.gov
Source: FDA See Less
109
I turned on the water and small black spots appeared as I was pouring it in a white cup. Then the water when I turned it on a little bit looked murky white. See Less
6
Package ID: 0652097001
Delivery conf at Teterboro: 92748909840515553021375525
Ordered small package that has been sitting at Teterboro since 12/8/21…it’s been a month and still not delivered. This is ridiculous!!!!! See Less
5.6K
For the past year, almost all personal or holiday cards sent through USPS in Clifton, NJ have been opened and checks, money, or lottery tickets have been removed. The opened envelopes (sometimes torn) are then delivered. Whether the destination is in-state or out-of-state, if mailed in Clifton,... See More envelopes are opened or never arrive. However, if mailed in any town other than Clifton, envelopes arrive at their stated destination and are always intact. Almost all of this mail passes through the Daniels Sectional facility, but only mail sent through Clifton disappears or is vandalized. Many individuals are experiencing problems, which include stealing and modifying checks with attempts to cash them. Bills went unpaid because the checks never arrived. Dusturbingly, a check was removed from a birthday card deposited in the mailbox directly outside the Post Office at 1114 Main Avenue. See Less
5.6K
Covid19 and influenza A, Richmond, IN, USA
3 weeks ago
Was diagnosed yesterday with covid19 and influenza A. I have had 2 Pfizer vaccines, but not due for a booster until February. My symptoms are fever, cough, sinus pain and congestion, body aches, fatigue, headache, scratchy throat, and chills. | Symptoms: Fever, Chills, Fatigue, Body Ache, Cough, Congestion, Headache See Less
#coronaviruscovid19 #covid19omicronvariant #richmond #indiana #unitedstates #fever #chills #fatigue #bodyache #cough #congestion #headache
108
I mailed a package from Lake Luzerne, NY on 12/8/21 and tracking states it arrived in Teterboro, NJ on 12/12/21. There are no further updates other than "in transit" and the package has not been delivered. On their website, it states this facility is permanently closed! Tracking... See More #9505 5124 5581 1342 2096 34 See Less
5.6K
World Health Products, llc. of Monroe, CT is recalling Jetfuel Diuretic UPC 859613000859, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
The GAT Sport Jetfuel... See More Diuretic was distributed thru the GAT Sport online store, Amazon and “Nationwide” retail stores. The recalled products bear the following lot code and Expiration Date information:
Brand: GAT Sport / Jetfuel Diuretic
Product: Jetfuel Diuretic
Size: 90 ct Bottle
Lot # 2003609
Exp. Date: 6/2023
Brand: GAT Sport / Jetfuel Diuretic
Product: Jetfuel Diuretic
Size: 90 ct Bottle
Lot # 2003610
Exp. Date: 5/2023
The lot code and expiration date are located on the bottom of the container, in bottom center of the panel, as pictured below.
This recall is being initiated because the Medium-Chain Triglycerides (MCT) oil powder ingredient contains an undeclared milk allergen.
This recall is being carried out with the knowledge of the Food and Drug Administration.
To date there have been no reports of illness involving the products addressed in this recall.
Customers with a milk allergy or sensitivity who have purchased the affected product are urged not to consume it and dispose of it or return it to the point of purchase.
In case you are experience harm from allergens or undeclared ingredients, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: World Health Products, LLC
Brand name: GAT Sport Jetfuel Diuretic
Product recalled: Diuretic
Reason of the recall: May contain undeclared milk
FDA Recall date: January 06, 2022
Check the full recall details on fda.gov
Source: FDA See Less
109
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