Recall Z-0785-2019 ยท CAC Apparatus, Autotransfusion
Medtronic Perfusion Systems
RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 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 | 1100 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
| K803277 | TYGON TUBING Electromedics, Inc., Jan 13, 1981 |