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.
- 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
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
- 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:
- Identify any affected devices in their possession.
- Ensure that all users or potential users of the affected devices are made aware of the recall notification.
- Complete and return the response form that was attached to the notice.
- 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.
Customers with questions about this recall should email Smith Medical at email@example.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|
Medical Device Recall Database entries:
- NORMOFLO Irrigation Warming Administration Set
- NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
- Potential Risk of Aluminum Leaching with Use of Certain Fluid Warmer Devices - Letter to Health Care Providers
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.