Cardinal Health Soft Pack Syringes Recall Overview
On February 2‚ 2024‚ Cardinal Health announced a recall for removal of certain Cardinal Health brand Monoject luer-lock and enteral syringes. The recall involves all sizes of Cardinal Health Monoject Luer-Lock Soft Pack Sterile Syringes and Cardinal Health Monoject Enteral Sterile Syringes with the ENFit connection due to safety concerns. The affected syringes are cautioned against use with syringe pumps and may pose risks if used in medical settings.
Background Information
Cardinal Health rebranded the Monoject syringes after acquiring them from Covidien. The FDA warned against using certain Cardinal Health Monoject syringes due to safety concerns when used with syringe pumps. This prompted a recall announcement by Cardinal Health to remove all affected syringes from the market. The FDA classified the recall as Class I‚ indicating the serious risks associated with using the recalled syringes in medical settings. Healthcare providers were advised to stop using the identified syringes and to report any adverse events or safety concerns related to their use.
Recall Announcement by Cardinal Health
Cardinal Health issued a voluntary product removal on February 2‚ 2024‚ in coordination with the U.S. Food and Drug Administration (FDA)‚ for all sizes of Cardinal Health brand Monoject Luer-Lock Soft Pack Sterile Syringes and Cardinal Health brand Monoject Enteral Sterile Syringes with the ENFit connection. The recall was initiated due to safety concerns related to the use of these syringes with syringe pumps and patient-controlled analgesia (PCA) pumps‚ which may result in pump performance issues and pose risks in medical settings.
Details of the Recall
Cardinal Health initiated a voluntary product removal‚ closely coordinated with the FDA‚ encompassing all sizes of Cardinal Health Monoject Luer-Lock Soft Pack Sterile Syringes and Cardinal Health Monoject Enteral Sterile Syringes with the ENFit connection. This recall‚ announced on February 2‚ 2024‚ was prompted by concerns regarding potential incompatibility issues when these syringes are used with syringe pumps and patient-controlled analgesia (PCA) pumps‚ which could lead to performance complications‚ including pump errors and risks in healthcare settings.
Products Affected by the Recall
The recall by Cardinal Health affects all sizes of Cardinal Health Monoject Luer-Lock Soft Pack Sterile Syringes and Cardinal Health Monoject Enteral Sterile Syringes with the ENFit connection. Specifically‚ the recall includes sizes such as 1‚ 3‚ 6‚ 12‚ 20‚ 35‚ and 60 mL. These syringes should not be used with syringe pumps due to potential incompatibility issues that may lead to performance complications and safety risks in medical settings.
FDA Warning and Involvement
The U.S. Food and Drug Administration (FDA) issued a warning advising consumers‚ healthcare providers‚ and facilities against the use of certain Cardinal Health Monoject luer-lock and enteral syringes. Following the announcement of the recall by Cardinal Health on February 2‚ 2024‚ the FDA emphasized the potential risks associated with using these syringes with syringe pumps and patient-controlled analgesia (PCA) pumps. The FDA classified the recall as Class I‚ indicating the serious nature of the safety concerns. Healthcare providers were alerted to cease the use of the identified syringes and report any adverse events or safety issues related to their utilization.
FDA’s Alert to Healthcare Providers
The U.S. Food and Drug Administration (FDA) issued a caution to healthcare providers and facilities regarding the use of Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps. The FDA advised against utilizing these syringes due to potential incompatibility issues that may arise when Cardinal Health Monoject syringes are employed with such pumps. The FDA is actively assessing the situation‚ emphasizing the risks associated with utilizing these syringes in medical settings.
Class I Recall Classification
The FDA has classified the recall of certain Cardinal Health Monoject syringes as Class I‚ indicating the most severe type of recall due to the serious risks associated with the product’s usage. Cardinal Health initiated this recall in close coordination with the FDA after identifying potential incompatibility issues when the syringes are used with syringe pumps‚ which may lead to performance problems such as overdose‚ underdose‚ and delays in therapy. Healthcare providers and facilities have been advised to discontinue the use of the affected syringes to prevent safety hazards.
Risks Associated with Using the Recalled Syringes
Using the recalled Cardinal Health Monoject syringes with syringe pumps can lead to potential compatibility issues‚ resulting in performance complications such as overdose‚ underdose‚ delays in therapy‚ and occlusion alarms. The FDA classified this recall as Class I‚ indicating the severe risks associated with utilizing these syringes with pumps in medical settings. It is crucial for healthcare providers to discontinue the use of the affected syringes to prevent adverse outcomes.
Potential Issues with Syringe Pumps
The dimensional changes in the Cardinal Health Monoject syringes‚ when used with syringe pumps or PCA pumps‚ may result in pump performance issues such as overdose‚ underdose‚ delays in therapy‚ and occlusion alarms. This incompatibility has raised concerns‚ leading to a Class I recall classification by the FDA‚ indicating the severity of risks associated with utilizing these syringes with pumps in healthcare settings. Healthcare providers have been advised to discontinue the use of the affected syringes to prevent adverse outcomes and ensure patient safety.
Performance Concerns and Safety Risks
The utilization of the affected Cardinal Health Monoject syringes with syringe pumps poses significant performance concerns and safety risks. These include the potential for overdose‚ underdose‚ delays in therapy‚ and occlusion alarms due to compatibility issues arising from the dimensional changes in the syringes when used with pumps. This issue prompted the FDA to classify the recall as Class I‚ emphasizing the seriousness of the risks associated with employing these syringes in medical settings.
Recommendations and Actions
Providers are strongly advised to cease using the affected Cardinal Health Monoject syringes with syringe pumps‚ given the compatibility concerns that have sparked risks of overdose‚ underdose‚ therapy delays‚ and occlusion alarms. The FDA’s classification of this recall as Class I underscores the urgency of discontinuing the utilization of these syringes to mitigate potential safety hazards and ensure patient well-being.
FDA’s Recommendations to Healthcare Providers
The U.S. Food and Drug Administration (FDA) advises healthcare providers and facilities to discontinue the use of Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps pending further evaluation of potential incompatibility issues. The FDA highlights concerns regarding the dimensional changes in these syringes when used with pumps‚ which may lead to pump performance issues such as overdosing‚ underdosing‚ therapy delays‚ and occlusion alarms. Prompt reporting of any adverse events or safety concerns related to these syringes is encouraged for better risk assessment and patient safety.
Reporting Adverse Events and Safety Concerns
Healthcare providers and facilities are encouraged to promptly report any adverse events or safety concerns associated with the use of Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia (PCA) pumps. The FDA urges vigilance in reporting incidents involving potential incompatibility issues that may result in pump performance problems‚ such as overdose‚ underdose‚ delays in therapy‚ and occlusion alarms. Reporting adverse events allows for a better understanding of the risks and ensures timely corrective actions to safeguard patient well-being.
Previous Recalls by Cardinal Health
On August 4‚ 2021‚ Cardinal Health initiated a nationwide recall of approximately 267 million Monoject Flush Prefilled Saline Syringes due to the potential reintroduction of air into the syringe after expulsion. In September 2023‚ a recall was made for certain Cardinal Health Monoject Luer-lock tip syringes to address compatibility concerns with syringe pumps‚ classified as Class I by the FDA.
August 2021 Recall of Monoject Flush Prefilled Saline Syringes
In August 2021‚ Cardinal Health initiated a nationwide recall of approximately 267 million Monoject Flush Prefilled Saline Syringes due to the potential reintroduction of air into the syringe after expulsion. The voluntary recall aimed to address the risk of injecting air into blood vessels‚ emphasizing patient safety concerns associated with using these syringes.
September 2023 Correction Recall for Luer-lock Tip Syringes
On September 20‚ 2023‚ Cardinal Health conducted a correction recall for specific Cardinal Health Monoject single-use Luer-lock tip syringes due to incompatibility concerns when used with syringe pumps. The FDA classified this corrective action as a Class I recall‚ highlighting the potential risks associated with using these syringes with certain medical devices and emphasizing the critical need for healthcare providers to adhere to the safety recommendations to ensure patient well-being.
Impact on Healthcare Facilities and Practices
The recall of Cardinal Health Monoject syringes has a significant impact on healthcare facilities and practices‚ requiring immediate cessation of using these syringes with syringe pumps. Healthcare providers must ensure compliance with the recall to prevent potential risks associated with overdose‚ underdose‚ delays in therapy‚ and occlusion alarms. Quick adherence to safety recommendations and swift adoption of alternative solutions are crucial to safeguard patient well-being and maintain the standard of care in medical settings.
Handling of the Recall in Medical Settings
The recall of Cardinal Health Monoject syringes necessitates a careful and swift response in medical settings. Healthcare facilities and practices are expected to promptly discontinue the use of these syringes with syringe pumps to mitigate potential risks of overdose‚ underdose‚ therapy delays‚ and occlusion alarms. Proper handling of the recall is crucial to ensuring patient safety and upholding the highest standards of care in healthcare environments.
Importance of Quick Compliance and Alternative Solutions
The swift compliance with the recall of Cardinal Health Monoject syringes is critical for healthcare facilities and practices to prevent potential risks associated with using these syringes with syringe pumps. Implementing alternative solutions promptly is essential to maintain patient safety and ensure continued delivery of quality care. Quick adaptation to alternative tools and practices underscores the commitment to minimizing any disruptions in healthcare services while prioritizing patient well-being.
Future Steps and Updates
As the Cardinal Health Soft Pack Syringes Recall unfolds‚ ongoing communication channels will provide updated information and guidance for healthcare providers and facilities. Stay informed through official FDA alerts and manufacturer notifications for any new developments‚ recommendations‚ or follow-up actions regarding the recall. Monitoring the situation and promptly implementing any further instructions are essential to ensure the continued safety and well-being of patients.
Communication Channels for Further Information
For further information and updates regarding the Cardinal Health Soft Pack Syringes Recall‚ healthcare providers and facilities can rely on official FDA alerts‚ manufacturer notifications‚ and dedicated communication channels. Ongoing communication will provide crucial updates‚ safety recommendations‚ and any additional actions related to the recall. Staying informed through these channels will ensure timely implementation of any new guidelines to protect patient safety and well-being.
Potential Developments and Follow-up Actions
As the recall situation evolves‚ potential developments and follow-up actions will be crucial in addressing the incompatibility issues with Cardinal Health Monoject syringes when used with syringe pumps. Continued collaboration between Cardinal Health‚ the FDA‚ and healthcare providers is essential to assess any new information‚ provide further guidance‚ and implement necessary corrective measures to enhance patient safety and prevent adverse events in medical settings.
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