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U.S. Department of Health and Human Services

Class 2 Device Recall RESERVOIR "Y" ADAPTER

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  Class 2 Device Recall RESERVOIR "Y" ADAPTER see related information
Date Initiated by Firm November 27, 2018
Create Date January 29, 2019
Recall Status1 Open3, Classified
Recall Number Z-0785-2019
Recall Event ID 81702
510(K)Number K803277  
Product Classification Apparatus, autotransfusion - Product Code CAC
Product 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.
Code Information BT920: GTIN/UDI Lot/Serial Numbers 10673978522460 216044420 10673978522460 216062719 10673978522460 216438180  BT926: GTIN/UDI Lot/Serial Numbers 10673978522477 215782209 10673978522477 215903433 10673978522477 216034158 10673978522477 216107790 10673978522477 216372963 10673978522477 216438301  
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 1100 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.
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