Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Recall
- Recall Number
- Z-0539-2026
- Event Number
- 97912
- Firm
- Medtronic Perfusion Systems
- FEI Number
- 1000116158
- Product Code
- JBP
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- October 20, 2025
- Posted
- November 18, 2025
- Address
- 7611 Northland Dr N, Brooklyn Park, MN, 55428-1088
Description
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
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.
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 [email protected]. " 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.
US Nationwide distribution in the states of Hawaii and New York.
3850 units