United StatesPenumbra System RED 68 Reperfusion Catheter (REF: RED68KIT; UDI: 00815948024113) with lots H00008699, H00008701, H00008702, H00008703, and C00020038 is affected; these devices were distributed worldwide, including the United States, Puerto Rico, Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, Philippines, Saudi Arabia, Thailand, and the United Arab Emirates. The devices were recalled because manufacturing issues may cause the reperfusion catheters to fracture.
What's being recalled
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Recalling firm: Penumbra, Inc., Livermore, CA, United States.
How to identify it
UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
The hazard
Due to manufacturing issues, reperfusion catheters may fractures
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AE, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, Philippines, Saudi Arabia, Thailand, and United Arab Emirates.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)