Infusion System Administration Set (infusion set) - recalled due to Use of the pump system potentially could cause over-infusion or under-infusion of therapy, USA

3 years ago •source www.fda.gov

Recall notice

Infusion System Administration Set (infusion set) - recalled due to Use of the pump system potentially could cause over-infusion or under-infusion of therapy photo #1

United States

Company name: CME America
Brand name: BodyGuard
Product recalled: Infusion System Administration Set (infusion set)
Reason of the recall: Use of the pump system potentially could cause over-infusion or under-infusion of therapy
FDA Recall date: July 08, 2020
Recall details: PRNewswire/ - CME America, a wholly owned subsidiary of BD (Becton, Dickinson and Company), announced a voluntary recall for all CME America BodyGuard® Infusion System Administration Sets (infusion sets) used with the company's BodyGuard® infusion pumps—that were distributed beginning May 2016 (see complete impacted product list below).  This action was initiated on June 16, 2020. As part of CME America's commitment to quality, following the previously announced recall (April 27, 2020) of the BodyGuard® Infusion Pump Systems, the company conducted additional flow-rate accuracy testing.

This testing revealed that some infusion sets do not meet the ±5% delivery accuracy for the system or the ±13% accuracy identified in the earlier recall notification (www.bd.com Therefore, the use of the pump system potentially could cause over-infusion or under-infusion of therapy and patient harm. Based on those test results CME America is providing additional information and customer actions regarding its previous recall to include all infusion sets used with the BodyGuard® infusion pump distributed beginning May 2016.

CME America has defined four categories of impacted infusion sets based on delivery inaccuracy variability, two of which (Category A and B) can continue to be used in accordance with the instructions in the recall letter (www.bd.com CME America also announced on April 27, 2020, the decision to suspend distribution of the BodyGuard® infusion pumps and to remove all existing products from the U.S. market. CME America will work with customers to address the latest expanded infusion set recall and will continue to maintain continuity of care during the COVID-19 pandemic. Until such time that the BodyGuard® pumps have been removed from the market, CMEA will supply accessories and infusion sets in "Category A" and "Category B" to support the infusion pumps, and customers can continue to use the products in accordance with the Operator's Manual and the additional mitigations outlined in the customer letter.

Affected Product Types:

- BodyGuard BodySet
- BodyGuard Microset with Needleless Adaptor
- BodyGuard Microsets
- BodyGuard Microset w/ Non-Vented Spike Connector
- BodyGuard set with Female Luer
- BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer
- BodyGuard Microsets with Filter
- Standard BodySet with Needleless Connectors
- BodyGuard Microset with Filter and Manual Priming Valve
- CMExpress Microbore Sets
- BodyGuard Microset with Male Luer Connectors
- CMExpress Needleless Y Site Microbore Set

Check the full recall details on www.fda.gov

Source: FDA

#medicaldevices #us

303

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I ordered from Mighty Jaxx and I ordered two items while they where on sale, they where, Freeny’s Hidden Dissectibles: One Piece! Tray of 12 and this is the link: https:// www .mightyjaxx. com/products/freenys-hidden-dissectibles-one-piece, then I also ordered Freeny’s Hidden Dissectibles: One Piece! (luffys gears edition) tray … See More
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AuroMedics Pharma Methocarbamol Injection - recalled due to Particulate Matter presence, USA

3 weeks ago •source www.fda.gov

Recall notice

Eugia US LLC (f/k/a AuroMedics Pharma LLC) has initiated a voluntary recall of lot number 3MC23011 of Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial) - 10mL Vial to the consumer level due to a customer product complaint for the presence of white particles floating … See More
inside of the vial.

Administration of an injectable product that contains particulate matter may result in local irritation or swelling. If the particulate matter reaches the blood vessels or is injected intravascularly it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Eugia US LLC has not received any reports of adverse events related to this recall.

Methocarbamol injection USP 1000 mg/10 mL (100mg/mL), is used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. It is packaged in 10 mL and packed as 25 (vials) X 04 (Printed E-Flute cartons) X 01 (Shipper) with NDC code as 55150-223-10. Eugia US LLC shipped the entire lot to wholesalers nationwide from Jan 12, 2024, through Jan 16, 2024.

The product can be identified by product name on carton and vial label and with lot number 3MC23011 and Exp. Date: Nov 2026 (NDC 55150-223-10) (See enclosed vial label). The product label is as shown in the image below.

Eugia US LLC (f/k/a AuroMedics Pharma LLC) is notifying its distributors by recall letters and is arranging for the return/replacement of all recalled products. Wholesalers, hospitals, pharmacies, institutions, and doctors with an existing inventory of the recalled product lot should discontinue use, stop distribution and quarantine the product immediately. If you have further distributed the recalled product lot, notify your accounts and/or any additional locations which may have received the recalled product. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

If you are experiencing any harm after using this product it is important to report it. It can help to detect & resolve outbreaks early and prevent others from being harmed, and it enables better surveillance. If symptoms persist seek medical attention.

Company name: Eugia US LLC
Brand name: Eugia US LLC
Product recalled: Methocarbamol Injection, USP 1000 mg/10 mL (100mg/mL) (Single Dose Vial)
Reason of the recall: Device & Drug Safety – Presence of Particulate Matter
FDA Recall date: March 28, 2024

Source: www.fda.gov
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AuroMedics Pharma Methocarbamol Injection - recalled due to Particulate Matter presence photo #1
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