| Date Initiated by Firm |
November 27, 2018 |
| Create Date |
January 29, 2019 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0786-2019 |
| Recall Event ID |
81702 |
| 510(K)Number |
K812292
|
| Product Classification |
Apparatus, autotransfusion - Product Code CAC
|
| Product |
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. |
| Code Information |
BTC93: GTIN/UDI Lot/Serial Numbers 10673978522545 215691544 10673978522545 215691545 10673978522545 215737228 10673978522545 215737229 10673978522545 215782206 10673978522545 215782207 10673978522545 215816859 10673978522545 215816860 10673978522545 215857423 10673978522545 215857424 10673978522545 215903431 10673978522545 215946277 10673978522545 216245142 10673978522545 215875581 10673978522545 215875582 10673978522545 215875583 10673978522545 216045172 10673978522545 216062720 10673978522545 216107788 10673978522545 216150361 10673978522545 216199988 10673978522545 216238209 10673978522545 216245141 10673978522545 216372965 10673978522545 216372966 10673978522545 216372967 10673978522545 216421235 10673978522545 216421236 10673978522545 216438179 BTC98: GTIN/UDI Lot/Serial Numbers 10673978522576 215782205 10673978522576 215903430 10673978522576 216034160 10673978522576 216062718 10673978522576 216238210 |
Recalling Firm/
Manufacturer |
Medtronic Perfusion Systems
7611 Northland Dr N
Brooklyn Park MN 55428-1088
|
| For Additional Information Contact |
Joey Lomicky
763-526-2494
|
Manufacturer Reason
for Recall |
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.
|
FDA Determined
Cause 2 |
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 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
RS.CFQFCA@medtronic.com.
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: carlos.j.alfonzo@medtronic.com. |
| Quantity in Commerce |
7587 units |
| Distribution |
Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Japan, and Sweden. |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database |
510(K)s with Product Code = CAC and Original Applicant = ELECTROMEDICS, INC.
|
