FDA MedWatch - NORMOFLO Irrigation Fluid Warmers and Warming Sets by Smiths Medical:

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TOPIC: NORMOFLO Irrigation Fluid Warmers and Warming Sets by Smiths Medical: Class I Recall - Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers

AUDIENCE: Patient, Health Professional, Risk Manager, Pediatrics, OBGYN, Geriatrics, Nephrology

ISSUE: Smiths Medical ASD is recalling the NORMOFLO Irrigation Fluid Warmer and Warmers Sets because of the potential for aluminum ions leaching into warmed fluids. When the fluid circulates through the patient’s body, the patient can be exposed to high levels of aluminum. Exposure to toxic levels of aluminum may not be easily recognized and exposure effects may cause serious adverse events including death.

There have been no complaints, injuries or reports of death for this issue.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: Fluid warming systems are used for warming blood, blood products, and intravenous solutions before use. There are several instances where fluid warmer products may be used, such as:

• When more blood is needed for patients suffering from blood loss due to trauma or surgery
• To rewarm patients after surgery to prevent hypothermia
• For irrigation in urology procedures

Health care providers use fluid warming systems in a hospital or clinical setting. Fluid warmers may be used over a full range of flow rates from slow to rapid.

RECOMMENDATIONS:  On August 13, 2021, Smiths Medical sent all affected customers an Important Medical Device Advisory notification letter.

The letter requested customers to take the following actions:

1. Identify any affected devices in their possession.
2. Ensure that all users or potential users of the affected devices are made aware of the recall notification.
3. Complete and return the response form that was attached to the notice.
4. Forward a copy of the notification and attachments to any customers they may have further distributed affected devices and request that they complete the response form. In addition, under a separate mailing, provide customers with a placard that contains instructions on how to mitigate the risk of exposure to aluminum when using the affected devices.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.