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Hospital Grade Power Cord, UL, Part # 66319, 055476… recallZ-1939-2010 · Medtronic Cardiovascular Revascularization & Surgical Therap · initiated Apr 21, 2010

Terminated All recalls posted in June 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Cardiovascular Revascularization & Surgical Therap or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-1939-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 21, 2010
Posted by the FDA
Jun 30, 2010
Recalling firm
Medtronic Cardiovascular Revascularization & Surgical Therap
Quantity
619 USA, 80 OUS
Product code
DWA
FDA submissions
K051303, K941921, K972894
Distribution
Worldwide distribution: USA, Latin America, Middle East, Japan, and Canada.

Product description

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 (models, lots, serial numbers)

Part # 66319 & 055476

Other devices under the same FDA submission

3 devices cleared under K051303, K941921, K972894 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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