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U.S. Department of Health and Human Services

Class 2 Device Recall Power cord used on BioConsole, autoLog, Sequestra

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  Class 2 Device Recall Power cord used on BioConsole, autoLog, Sequestra see related information
Date Initiated by Firm April 21, 2010
Date Posted June 30, 2010
Recall Status1 Terminated 3 on December 24, 2011
Recall Number Z-1939-2010
Recall Event ID 55749
510(K)Number K941921  K051303  K972894  K953118)  
Product Classification power cord on cardiopulmonary bypass - Product Code DWA
Product Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufacturing Co. beginning in February 2003. The cords are a detachable unit, supplied with the instruments listed below:
Medtronic Bio-Console¿ 550 centrifugal pump console, Model #95180, Catalogue # 95180, E95180, R95180.

Medtronic Bio-Console¿ 560 centrifugal pump consoles Model # 560BC, Catalogue # 560BC, 560BCS, 560BCS1.

Medtronic autoLog¿, Model # ATLG110, Catalogue # ATLG110, ATLG110E
ATLG110R.

Medtronic Sequestra¿ 1000, Model #SEQ1000, Catalogue # SEQ1000, SEQ1000E, SEQ1000R.
Code Information Part # 66319 & 055476
Recalling Firm/
Manufacturer		 Medtronic Cardiovascular Revascularization & Surgical Therap
7611 Northland Dr N
Brooklyn Park MN 55428-1088
For Additional Information Contact
763-391-9000
Manufacturer Reason
for Recall		 The potential risks during the use of this power cord include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires. Although Medtronic has received no reports of adverse events related to the affected cord, a failure may potentially lead to serious adverse health consequences, depending on the device, and therapy being interrupted. This Field Notificatio
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were sent on 4/21/10 a Medtronic "Urgent Medical Device Recall Notice" letter dated April 19, 2010. The letter was addressed to their customers and described the problem and the product involved. They recommended to discontinue use of the AC power cords and to destroy them. Requested consignees to fill out the attached Medtronic Recall Certificate (FCA 1005), and return it to Medtronics.
Quantity in Commerce 619 USA, 80 OUS
Distribution Worldwide distribution: USA, Latin America, Middle East, Japan, and Canada.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWA and Original Applicant = MEDTRONIC BIO-MEDICUS, INC.
510(K)s with Product Code = DWA and Original Applicant = MEDTRONIC BLOOD MANAGEMENT
510(K)s with Product Code = DWA and Original Applicant = MEDTRONIC PERFUSION SYSTEMS
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