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: DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
- Product Codes for CYSTO Pack PGYBK/89-5721.03 and GU TUR BASIN SET PGYBK/89-6425.07: See Recall Database Entry
- Manufacturing Dates: November 8, 2017 to July 22, 2021
- Distribution Dates: November 29, 2017 to July 21, 2021
- Devices Recalled in the United States: 2,856
- Date Initiated by Firm: September 2, 2021
DeRoyal Industries’ procedure packs include an irrigation warming set that may be used with a fluid warming device. Fluid warming devices may be used by health care providers to:
- Provide more blood for patients suffering from blood loss due to trauma or surgery.
- Rewarm patients after surgery to prevent hypothermia.
- Irrigate during urology procedures.
Reason for Recall
DeRoyal Industries, Inc. is recalling their procedure packs which contain the recalled Smiths Medical NORMOFLO Irrigation Warming Set because of the potential for aluminum ions to leach into warmed fluids. If this occurs, contaminated fluids can circulate through a patient’s body and the patient can be exposed to high levels of aluminum. Exposure to harmful levels of aluminum may not be easily recognized and the effects could cause serious adverse events including cognitive decline, dementia, nervous system damage, and even death. Patients who have symptoms may experience bone or muscle pain or weakness, anemia, seizures, or coma.
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
- Older adults
- Patients with poor kidney function or on dialysis
What to Do
On September 03, 2021, DeRoyal Industries, Inc. sent all affected customers an “Important Medical Device Recall” letter.
The letter requested customers to:
- Identify the affected products.
- Complete the notice of credit form provided with the recall notification and return it to DeRoyal Industries, Inc.
- Quarantine the affected products and return them to DeRoyal Industries, Inc.
- Forward a copy of the recall notification to any customers who may have further distributed the affected products, asking them to identify, quarantine, and return the affected products to DeRoyal Industries, Inc.
Customers with questions about this recall should email [email protected].
- Medical Device Recalls Database Entry
- Related FDA Recall Classification Notice: 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
- 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.