Recall Z-1424-2009 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
Medtronic Cardiovascular Revascularization & Surgical Therap
Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration Kits
| Date | Jun 23, 2009 (initiated Feb 25, 2009) |
| Status | Terminated |
| Reason | Sterility may be compromised. Non-vented caps that connect to the 3-way stopcock attached to the transfer spike could prevent Ethylene Oxide from contacting the inside surfaces of the stopcock during sterilization, leading to a potentially non-sterile product. Use of the product may cause serious health consequences from potential sepsis/infection and the associated remote risk of death. |
| Root cause | Device Design |
| Action | Consignees were sent a Medtronic "Urgent Medical Device Recall Notice" letter dated March 5, 2009. The letter was addressed to Risk Manager. The letter described the product and problem and requested the consignee to complete, sign and return the certificate acknowledgement. |
| Quantity | 20 units |
| Distribution | Distribution to one medical facility in MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K800178 | EXTRACORP.'S INTERSEPT CUS. TUBING PK. Extracorporeal Medical Specialities, Inc., Feb 21, 1980 |