FDA Class I Recalls: DeRoyal procedure packs with NORMOFLO Irrigation Warming Set, and Imperative Care Inc. ZOOM 71 Reperfusion Catheter
The U.S. Food and Drug Administration (FDA) has issued a Class I recall for DeRoyal procedure packs with NORMOFLO Irrigation Warming Set and Imperative Care Inc. ZOOM 71 Reperfusion Catheter, according to a release.
DeRoyal procedure packs with Smiths Medical NORMOFLO Irrigation Warming Set
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.
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 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
Imperative Care Zoom 71 Reperfusion Catheter
Imperative Care Inc. is recalling specific lots of this product due to increased risk of the Zoom 71 Reperfusion Catheter breaking at a certain point (distal tip) during use, such as when the catheter is retracted forcefully. If the device breaks during use, this could lead to fractured pieces left inside the patient’s bloodstream resulting in serious adverse events such as blockage of blood vessels, stroke, and death. There have been nine reports of serious injuries. There have been no deaths reported.
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: ZOOM 71 Reperfusion Catheter
Devices Recalled in the United States: 3,098
Distribution Date: September 23, 2020 to August 9, 2021
The ZOOM 71 Reperfusion Catheter is used with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum pump) to remove blood clots in the brain of a patient within eight hours of an acute ischemic stroke caused by blocked or narrowed arteries.
