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Ultrasound Gel - recalled due to product is contaminated with bacteria, USA

2 years ago source www.fda.gov

Recall notice

United States

Company name: Eco-Med Pharmaceutical
Brand name: Multiple brand names
Product recalled: Ultrasound Gel
Reason of the recall: Product is contaminated with bacteria (Burkholderia cepacia complex)
FDA Recall date: August 04, 2021
Recall details: Etobicoke, Ontario (August 4, 2021) – Eco-Med Pharmaceuticals, Inc. today commenced a voluntary recall of certain lots of its Eco-Gel 200 ultrasound gel due to bacterial contamination. The product is also distributed as MediChoice Ultrasound Gel by Owens and Minor and Mac Medical Supply. These ultrasound gels are non-sterile and not indicated for sterile procedures. Eco-Med is instructing all health care facilities to identify the affected products by lot number and immediately destroy or return products from affected lots to Eco-Med. Affected product lot numbers are below:

- Product: Eco Gel 200 MediChoice M500812

- Lot Numbers and Initial Distribution Date:

B029 March 26, 2021
B030 March 30, 2021
B031 April 5, 2021
B032 April 7, 2021
B040 April 26, 2021
B041 April 26, 2021
B048 May 7, 2021
B055 May 26, 2021

Additionally, Eco-Med is instructing all health care facilities to immediately stop use and quarantine all lots of the following ultrasound gels distributed under these brand names in these geographies:

EcoGel 200, by Eco-Med (Canada)
MediChoice Ultrasound Gel, by Owens & Minor (United States)
MediChoice Ultrasound Gel, by Mac Medical Supply Co Inc. (United States)
EcoGel 200, by Active Crystal Inc (Canada)
EcoGel 200, by Agencia Matamoros (Honduras)
EcoGel 200, by Cardinal Health Canada
EcoGel 200, by CMCC Supply Centre and Bookstore (Canada)
EcoGel 200 Blue, by Christie Innomed Inc. (Canada)
EcoGel 200, by Dectro International (Canada)
EcoGel 200, by Medline Canada
EcoGel 200, by Dunbar Medical (Canada)
EcoGel 200, by Eastern Medical Supply Ltd (Canada)
EcoGel 200, by Global Medical Solution (NZ) LTD (New Zealand)
EcoGel 200, by Good-link Electronics Ltd. (Hong Kong)
EcoGel 200, by Henry Schein Arcona (Canada)
EcoGel 200, by Maranda Lauzon Inc (Canada)
EcoGel 200, by Medi’s Part Ltd. (Thailand)
EcoGel 200 Blue, by MJM Distributing (Canada)
EcoGel 200, by Ortho Canada (Canada)
EcoGel 200, by So medico SDN BHD (Malaysia)
EcoGel 200 and EcoGel 200 Blue, by STAT Healthcare Corporation (Canada)
EcoGel 200 and EcoGel 200 Blue, by The Stevens Company Limited (Canada)
EcoGel 200, by Strathroy Middlesex General Hospital (Canada)
EcoGel 200, by Trimedic Supply Network Ltd. (Canada)
EcoGel 200, by Vitality Depot (Canada)
Chattanooga Conductor USA, by DJO Global (United States)
Conductor Australia, by DJO Australia
DJO Conductor, by DJO Global (United States)
Liquasonic, by Athena Medical Products Inc. (United States)
Medico, by Medico Inc. (Canada)
Medline, by Medline Industries Inc. (United States)
NDC Eco-Gel 200 Ultrasound Gel, by NDC Inc. (United States)
Omni, by Accelerated Care Plus Leasing Inc. (United States)
Red Medical Ultrasound Gel Blue, by Red Medical Supplies Ltd. (Canada)
Smart 200, by Smart Technology and Product Co., Ltd (Thailand)

Eco-Med has initiated this recall and quarantine due to bacterial contamination in the affected lots of ultrasound gel with Burkholderia cepacia complex (Bcc). The source(s) of the bacterial contamination is currently unknown. Eco-Med is conducting a comprehensive investigation to determine the root cause of this contamination and take all necessary corrective action.

The effects of the bacteria, Burkholderia stabilis, a member of the Burkholderia cepacia complex (Bcc), vary widely, ranging from no symptoms at all to serious infections. Bcc bloodstream infections may result in sepsis and in certain cases, potentially death. Use of ultrasound gels manufactured by Eco-Med have been associated with at least 15 infections to date, including bloodstream infections. Additional infections have been identified that may also be associated with the use of this ultrasound gel and investigation is ongoing. Potential routes of transmission leading to bloodstream infections associated with a contaminated nonsterile gel may have included the use of the gel for visualization prior to, in preparation for, or during an invasive procedure or application of the gel inside the sterile ultrasound probe sleeve during an invasive procedure using ultrasound guidance.

Check the full recall details on www.fda.gov

Source: FDA

#medicaldevices #recall #us

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ADM Animal Nutrition announced that specific lots may contain elevated levels of calcium, phosphorus, magnesium, sodium and/or chloride and may harm chickens, swine, beef cattle and equine. ADM (NYSE: ADM), is recalling the following products: Pen Pals® Chicken Starter-Grower 25-lb bag (Product No 70009ACF46); Pen Pals Chicken … See More
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The lot number for the Pen Pals Chicken Starter-Grower 25-lb bags involved in this recall is Lot 507650QN. This product may contain elevated levels of calcium and phosphorus, which could lead to leg deformities, trouble standing and walking, and can be fatal to chickens. This product was distributed between Feb. 29, 2024 and March 8, 2024, and could have been purchased through distributors in Iowa and Missouri.

The lot number for the Pen Pals Chicken Starter-Grower 50-lb bags and Pen Pals® Chicken Starter-Grower 25-lb case involved in this recall is Lot 506942QN. These products may contain elevated levels of magnesium, which can cause bone deformities, slow growth rate, watery feces and can be fatal to chickens. These products were distributed between Feb. 28, 2024 and March 14, 2024, and could have been purchased through distributors in Missouri, Ohio, South Carolina, Iowa, California and Oregon.

The lot number for the MoorMan’s ShowTec Sale Burst w/DF DEN 50-lb. bags involved in this recall is Lot 506664QN. This product may contain increased levels of sodium and chloride, which can lead to reduced feed intake, thirst and diarrhea. This product was distributed between Feb. 16, 2024, and March 1, 2024, and could have been purchased through distributors in Iowa, Wisconsin and Colorado.

The lot number for the MoorMan’s ShowTec Burst Starter w/DF CTC/DEN 50-lb. bags involved in this recall is Lot 506640QN. This product may also contain increased levels of sodium and chloride. This product was distributed between Feb. 16, 2024, and March 1, 2024, and could have been purchased through distributors in Iowa, Wisconsin and Colorado.

The lot number for the ShowTec BB 18 BMD 50-lb. bags involved in this recall is Lot 506939QN. This product may also contain increased levels of sodium and chloride. This product was distributed between Feb. 16, 2024, and March 1, 2024, and could have been purchased through distributors in California, Illinois, Arizona, Missouri, and Iowa. The lot number for the ShowTec 14.5/6 BMD 50-lb. bags involved in this recall is Lot 507900QN. This product may contain increased levels of calcium, which could cause reduced feed intake and feed conversion. This product was distributed between March 8, 2024, and March 18, 2024, and could have been purchased through distributors in Iowa.

The lot number for the AMPT-A CTC/IGR 50-lb. bags involved in this recall is Lot 507828QN. This product may contain increased levels of sodium, which could cause loose stools and central nervous system issues. This product was distributed on March 1, 2024, and could have been purchased through distributors in Missouri.

The lot number for the ShowTec Hi Fat 18 BMD 50-lb. bags involved in this recall is Lot 505791QN. This product may contain increased levels of magnesium and calcium, which could cause reduced feed intake and feed conversion. This product was distributed between Jan. 26, 2024, and Feb. 7, 2024, and could have been purchased through distributors in Iowa, Oregon and California.

The lot number for the Seniorglo 50-lb. bags involved in this recall is Lot 505426QN. This product may contain increased levels of calcium, which could cause weight loss and the animal to become weak and listless. This product was distributed between Jan. 24, 2024, and Feb. 1, 2024, and could have been purchased through distributors in Missouri, Illinois, Ohio, Tennessee as well as from ADM locations in Glencoe, Minn., Springfield, Mo. and Dublin, Texas.

The lot number for the MotivAte 12-15 DEN 50-lb. bags involved in this recall is Lot 507330QN. This product may contain increased levels of calcium and phosphorus, which could cause reduced feed intake and feed conversion This product was distributed on Feb. 27, 2024, and March 4, 2024, and could have been purchased from ADM locations in Glencoe, Minn. and Columbus, Neb. After receiving a customer complaint related to swine refusing to eat feed from a single lot of MoorMan’s ShowTec Sale Burst w/DF DEN, ADM immediately investigated and discovered that the company’s animal feed manufacturing facility in Quincy, Illinois, experienced an equipment failure issue that impacted ingredient distribution in the plant.

The company initiated the recall once it was confirmed that these specific lots could contain harmful levels of calcium, phosphorus, magnesium sodium, and/or chloride. ADM has been in direct contact with the customers and distributors involved in this recall, and all product has been removed from retail shelves.

The lot number can be found at the bottom of the label. Customers who have purchased the recalled feed should immediately stop using it and return it to their distributor or directly to ADM Animal Nutrition for a full refund.

Company name: ADM Animal Nutrition
Brand name: Multiple Brand Names
Product recalled: Chicken Feed, Swine Feed, Cattle Feed, Horse Feed
Reason of the recall: Specific lots may contain elevated levels of calcium, phosphorus, magnesium, sodium and/or chloride and may harm chickens, swine, beef cattle and equine.
FDA Recall date: April 01, 2024

Source: www.fda.gov
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