Hospital Grade Power Cord, UL, Part # 66319, 055476, manufactured by Electri-Cord Manufacturing Co. beginning in Februar
FDA device recall Z-1939-2010 · posted 2010-06-30 · Terminated
Recall details
- Recalling firm
- Medtronic Cardiovascular Revascularization & Surgical Therap
- 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
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DWA
- Quantity affected
- 619 USA, 80 OUS
- Distribution
- Worldwide distribution: USA, Latin America, Middle East, Japan, and Canada.
- Date initiated
- 2010-04-21
- Date posted
- 2010-06-30
- Date terminated
- 2011-12-24
- Location
- Brooklyn Park, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIO-CONSOLE, MODEL 560 (K051303) | Medtronic Perfusion Systems | 2005-06-10 |
| AUTOTRANSFUSION APPARTUS (AUTOLOG) (K972894) | Medtronic Blood Management | 1998-04-27 |
| BIO-MEDICUS BIO-CONSOLE MODELS 540, 540A,B,C,D,E, & 550 (K941921) | Medtronic Bio-Medicus, Inc. | 1994-07-20 |