FDA Recall Open, Classified

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.

Recall: Z-0786-2019 · Initiated November 27, 2018

Recall

Recall Number: Z-0786-2019
Event Number: 81702
Firm: Medtronic Perfusion Systems
FEI Number: 1000116158
Product Code: CAC
Status: Open, Classified
Root Cause: Process control
Initiated: November 27, 2018
Address: 7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

Description

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.

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 Customer Service at 1-800-854-3570 to initiate a product return. Your local Medtronic Representative can assist you in the return and replacement of this product as necessary. 3. Complete the enclosed Customer Confirmation Certificate and email to [email protected]. If you have any questions about this action, please contact your Medtronic representative or call Director, Cardiac and Vascular Group, at 763-526-2513 or email: [email protected].

Distribution

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Japan, and Sweden.

Quantity

7587 units