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  5. Smiths Medical Recalls NORMOFLO Irrigation Fluid Warmers and Warming Sets Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers
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Smiths Medical Recalls NORMOFLO Irrigation Fluid Warmers and Warming Sets Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

  • Product Names: NORMOFLO Irrigation Fluid Warmer and NORMOFLO Irrigation Warming Set
  • Product Codes: See recall database
  • Model Numbers: See full list of affected medical devices
  • Manufacturing Dates: January 1994 to July 2021
  • Distribution Dates: January 1994 to present
  • Devices Recalled in the U.S.: 520,163
  • Date Initiated by Firm: August 6, 2021

Device Use

NORMOFLO Fluid Warming Device

NORMOFLO Fluid Warming Device

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.

Reason for Recall

Smiths Medical ASD, Inc. 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.

Who May Be Affected

  • Pediatric patients, particularly neonates and infants
  • Pregnant women
  • Elderly
  • Patients with poor renal function or on dialysis

What to Do

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.

Contact Information

Customers with questions about this recall should email Smith Medical at fieldactions@smiths-medical.com.

Full List of Affected Devices

Affected Product Model Name Affected Product Model Number
Level 1 Fluid Warmer H-1000, H-500
Level 1 Fluid Warming System H-1025, H-1028, H-1200
Level 1 Normothermic I.V. Fluid Administration Set D-100, D-300, D-50, D-60HL, DI-100, DI-300, DI-50, DI-60HL, D-70, DI-70
NORMOFLO Fluid Warmer H-1100, H-1129
NORMOFLO Irrigation Warming Set IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700

Additional Resources

Medical Device Recall Database entries:

How Do I Report a Problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

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