Recall Z-2736-2015 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
Medtronic Perfusion Systems
MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A, BB7M38Rll, M450013B, BB8N86R4, HY2U43R9, 8C72R4, M650123A, HY8R55R ,TL7M46R7, M971406C, M450013B, 7U65R2, M394415A, M450013B. Enables the perfusionist to manage the
| Date | Sep 4, 2015 (initiated Aug 18, 2015) |
| Status | Terminated |
| Reason | Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were sent a Medtronic "Urgent Medical Device Recall" letter dated August 2015. The letter was addressed to "Risk Manager". The letter described the problem and the product involved in the recall. Informed consignees that no action is needed for product that has been used, but patients should continue to be managed in accordance with their standard patient management protocol. For unused product they recommend to immediately quarantine and return the affected product to Medtronic. Contact Customer Service at 800-854-3570 and reference RADAR #253277 to initiated a return and credit |
| Quantity | Total 1594 (1306 US, 288 OUS) |
| Distribution | Worldwide Distribution-US (nationwide) including the states of AL, AR, CA, CO, FL, HI, ID, IN, KS, LA, MA, MS, MO, NY, NJ, OH, PA, TN, TX, UT, and WI, and the countries of Bolivia, Denmark, Dominican Republic, Italy, Latvia, Lebanon, Mexico, Panama, Singapore, Venezuela, and Zambia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012538 | TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE Medtronic Vascular, Aug 23, 2001 |
| K122811 | CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE Medtronic, Inc., Oct 12, 2012 |
| K800178 | EXTRACORP.'S INTERSEPT CUS. TUBING PK. Extracorporeal Medical Specialities, Inc., Feb 21, 1980 |
| K891687 | EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE Medtronic Blood Systems, Inc., May 31, 1989 |