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.
This recall has been terminated (originally issued June 30, 2010).
- Recall Initiated
- April 21, 2010
- Posted
- June 30, 2010
- Terminated
- December 24, 2011
- Recall Number
- Z-1939-2010
- Quantity
- 619 USA, 80 OUS
- Firm Location
- Brooklyn Park, MN
- Official Source
- View on FDA website ↗
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
Distribution
Worldwide distribution: USA, Latin America, Middle East, Japan, and Canada.
Lot / Code Info
Part # 66319 & 055476
Root Cause
Nonconforming Material/Component
Action Taken
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.