Penumbra System RED 68 Reperfusion Catheter REF: recall status
Notice names this product. Penumbra’s Penumbra System RED 68 Reperfusion Catheter REF is named in FDA Class II recall Z-2770-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: Due to manufacturing issues, reperfusion catheters may fractures Identifying details: UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038. Units affected: N/A. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
Penumbra System RED 68 Reperfusion Catheter REF
Company / brand
Penumbra
Lot / serial / date codes
UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038
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 Emirates.
Agency product description and boundaries
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.