DeRoyal—Procedure Packs Containing Smiths NORMOFLO Irrigation Warming Sets: Warming Sets May Leach Aluminum Ions into Warming Fluids​ [FDA Class I]

ECRI's complete weekly summary of medical device hazard and recall information is available in ECRI's Health Device Alerts. For more information contact us at clientservices@ecri.org.

Problem:FDA's Center for Devices and Radiological Health (CDRH) states that the above kits may contain NORMOFLO irrigation warming sets, which were recalled by Smiths because they may leach aluminum ions into warming fluids. FDA's CDRH also states that the manufacturer initiated...