Penumbra, Inc.: Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT

Hazard

Due to manufacturing issues, reperfusion catheters may fractures

Details from the source

Reason for recall: Due to manufacturing issues, reperfusion catheters may fractures Distribution: 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 Emi Quantity: N/A Lot/code info: UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038

UPC codes

00815948024113

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.