Tuesday, June 18, 2024

Avanos Initiates Recall of Feeding Tube Kits Due to Sterilization Issue

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The Food and Drug Administration (FDA) has classified a recall of Avanos Medical’s MIC Gastric-Jejunal Feeding Tube Kits as Class I, indicating the highest level of risk where usage might lead to serious injuries or death. This recall is a direct response to concerns over the sterility of pre-filled syringes included in these kits, supplied by Nurse Assist, LLC, highlighting the critical nature of ensuring product safety in medical devices.

The pre-filled syringes are an essential component of the feeding tube kits, used for irrigation purposes, which, if contaminated, can introduce harmful bacteria directly into the patient’s body, potentially leading to life-threatening infections. Class I recalls are reserved for situations where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death, underscoring the severity of the issue with these kits.

Avanos Medical has acted swiftly to address this issue, notifying healthcare providers and distributors about the recall and providing guidance on how to manage affected products. This incident serves as a reminder of the importance of rigorous quality control and the need for continuous vigilance in the manufacturing and distribution of medical devices to ensure the safety and well-being of patients.

FDA Oversees Avanos Medical Recall of Feeding Tube Kits Due to Sterility Concerns, Ensuring Patient Safety

The FDA’s involvement and classification emphasize the regulatory oversight in place to protect public health, acting as a critical checkpoint in the lifecycle of medical products. Through collaboration between manufacturers, healthcare providers, and regulatory bodies, steps are taken to mitigate risks and prevent potential harm to patients, reinforcing the healthcare system’s commitment to patient safety.

Avanos Medical, Inc., has initiated a recall for specific lots of its MIC Gastric-Jejunal Feeding Tube kits, including those with ENFit Connectors. The recall affects kits distributed between January 31, 2022, and December 7, 2023, totaling 61,427 devices in the United States. The recall was triggered on January 16, 2024, following a recall by Nurse Assist of their 0.9% sodium chloride and sterile water for irrigation USP syringes due to sterility concerns.

These syringes, intended for irrigation, are a component of Avanos’s feeding tube kits and pose a risk of infection if used, as any open wound exposed to non-sterile products could potentially lead to severe patient outcomes. It’s important to note that to date, there have been no reported complaints, injuries, or fatalities linked to this issue.

Feeding Tube

Avanos Directs Immediate Action on Feeding Tube Kits to Safeguard Patient Health

Avanos has taken swift action by sending an Urgent Medical Device Recall notice to all customers potentially affected by this issue. The notice outlines specific steps for healthcare providers to mitigate risks, including continuing normal post-operative care for any newly placed MIC GJ tubes and following a detailed Daily Care & Maintenance Checklist. This checklist emphasizes assessing patients for signs of pain, infection, or any adverse reactions related to the tube placement.

Facilities in possession of the recalled lots are advised to quarantine these products immediately. Avanos has also provided instructions for the destruction of affected products within facilities’ protocols or returning them for destruction if unable to do so internally. Furthermore, the company has requested that all healthcare facilities identify and notify their distribution partners about the recall to prevent further use of these kits.

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Resource: Food and Drug Administration, March 14, 2024

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