Irrigation Warming Set Recall Issued For DeRoyal Procedure Packs Due to Aluminum Leaching

Nearly 3,000 surgical procedure packs that include fluid irrigation warming sets, which are used to rewarm patients after surgery and prevent blood loss, are being recalled due to a risk they could leach potentially life-threatening levels of aluminum ions into patients.

The FDA announced the DeRoyal Procedure Pack Recall on October 6, giving it a Class I recall designation, since continued use of the product could cause severe injury or death.

The procedure packs contain NORMOFLO Irrigation Warming Sets by Smiths Medical, which were included in a fluid warming device recall issued last month, after health officials recognized they may release too much aluminum.

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The irrigation warming sets included with the procedure packs are used with fluid warming devices. These devices are typically used to provide more blood for patients suffering from blood loss, rewarm patients after surgery, and to irrigate during urology procedures. However, the irrigation sets may release a quantity of aluminum which may significantly exceed the FDA threshold value of 25 mcg/L.

The FDA warns that high levels of aluminum exposure could cause patients to experience symptoms like bone or muscle pain and weakness, anemia, seizures, or coma. For high-risk individuals, such as pregnant women, infants or those with other co-morbidities and diseases, the recalled irrigation sets pose a risk of serious and potentially fatal health consequences, the agency warns.

There have been no reports of injuries or deaths due to aluminum leaching regarding the DeRoyal products.

On September 15, the FDA issued a letter to healthcare providers, warning of the aluminum leaching problem, which was linked to several fluid warmer Class I recalls impacting millions of Smiths Medical ASD, Inc., Eight Medical International, Smisson-Cartledge Biomedical, and Vyaire Medical products.

The Smiths Medical ASD, Inc. recall included approximately 520,163 NORMOFLO Irrigation Fluid Warmers and Warmer Sets. This latest recall involves nearly 3,000 additional sets, which were included with the DeRoyal procedure packs.

The FDA recommends healthcare professionals to be aware of adverse clinical effects and symptoms of high levels of aluminum exposure, which may cause a myriad of neurological effects and blood and metabolic derangements, such as increased levels of calcium or interference with iron absorption leading to anemia.

The agency also instructs clinicians to review the applicable recall notices from each company for specific steps to take to mitigate aluminum leaching events.

DeRoyal sent letters to all affected customers on September 3 calling on them to identify the affected products in their inventories, complete a notice of credit form provided with the recall notification, and return it. Customers are also being asked to quarantine affected products and return the product to DeRoyal Industries, Inc.


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