—#217136

Product

Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03

FDA product code: JBP — Activated Whole Blood Clotting Time
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K860122
Affected lot / code info: UDI/DI 20763000433844, Lot Number 232135734

Why it was recalled

Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Medtronic issued an Urgent Medical Device Correction notice to its consignees on 10/20/2025 via US mail. The notice explained the issue, potential risk, and requested the following actions be taken: " Please do not open, handle, or use the affected product. " Wear appropriate Personal Protective Equipment (PPE), such as gloves and protective clothing, to review your inventory for the listed lot number. " If you have this lot number in your inventory, place the affected product, including packaging and Instructions for Use, in a clearly marked biohazard bag or container. " Dispose of the biohazard material in accordance with your facility s procedures and all applicable local, state, and federal regulations for biohazardous waste. " Complete the enclosed Customer Confirmation Form and email to RS.CFQFCA@medtronic.com. " Contact Medtronic Customer Service at 1-800-854-3570, Option 1 then Option 4, and reference this communication to initiate to arrange for credit or replacement product. " Please maintain a copy of this communication in your records. For questions regarding this communication, please contact your Medtronic Field Representative.

Recalling firm

Firm: Medtronic Perfusion Systems
Address: 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

Distribution pattern: US Nationwide distribution in the states of Hawaii and New York.

Timeline

Recall initiated: 2025-10-20
Posted by FDA: 2025-11-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217136. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.