Compare the complete identifiers. Name similarity alone is not a confirmed match.
Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT
| Product or model | Codes and lots | Quantity | Recall number |
|---|---|---|---|
| Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT | UDI: 00815948024113/Lots: H00008699, H00008701, H00008702, H00008703, and C00020038 | N/A | Z-2770-2026 |
The agency's statement is shown without a site-authored severity score.
Due to manufacturing issues, reperfusion catheters may fractures
Agency classification: Class II
Only instructions associated with this recall event qualify as an action.
Consumer action is not available in the associated official record. The site does not infer or generate a replacement.
The linked agency record controls if any information differs.
Official scope
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.
Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.
No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.
