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Can make you unwell for a while. Do not eat it.

Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT

Check your package for

UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
Why
Due to manufacturing issues, reperfusion catheters may fractures
Distributed
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.
Company
Penumbra, Inc.
Announced
Recall began
Read the official notice

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Local Recall