Recall Z-0786-2019 ยท CAC Apparatus, Autotransfusion
Medtronic Perfusion Systems
SUCTION / ANTICOAGULATION ASSEMBLY (a) BTC93 (b) BTC98 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.
| Date | Nov 27, 2018 |
| Status | Open, Classified |
| Reason | Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit. |
| Root cause | Process control |
| Action | The firm, Medtronic, began notifying US consignees on 27-Nov-2018 via hand delivery to be followed up with a UPS 2-Day communication titled "URGENT MEDICAL DEVICE RECALL" to each listed consignee that does not confirm hand delivery. Communications OUS also began 27-Nov-2018 using locally approved methods. The letter described the product, problem and actions to be taken. Customers were requested to do the following: 1. Identify and quarantine all unused affected product as listed in your inventory. 2. Return all unused affected product in your inventory to Medtronic. Contact Medtronic Cust |
| Quantity | 7587 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Japan, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K812292 | AUTOTRANS BT795 Electromedics, Inc., Oct 23, 1981 |