Date Initiated by Firm | August 19, 2015 |
Date Posted | September 02, 2015 |
Recall Status1 |
Terminated 3 on May 24, 2017 |
Recall Number | Z-2545-2015 |
Recall Event ID |
71963 |
510(K)Number | K012218 |
Product Classification |
Pacemaker, cardiac, external transcutaneous (non-invasive) - Product Code DRO
|
Product | MediTrace Cadence Adult Multi-Function Defibrillation Electrodes
Item Code:22550PC |
Code Information |
Lot Numbers: 517521X, 519835X |
Recalling Firm/ Manufacturer |
Covidien LLC 60 Middletown Ave North Haven CT 06473-3908
|
For Additional Information Contact | SAME 203-492-5000 |
Manufacturer Reason for Recall | Multi-Function Defibrillation Electrodes, Pre connect-
potential for damage to the wire insulation may
result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns |
FDA Determined Cause 2 | Process control |
Action | Medtonic/Covidien issued recall letter on August 19, 2015. Customers were notified via Federal Express and the letter instructs customers to discontinue use of the product and return all inventory to Medtronic (Covidien), 2 Ludlow Park Drive, Chicopee, MA 01022, Attention: Field Action Returns.
Contact your Medtronic representative or Customer Service at (800)-882-5878. |
Quantity in Commerce | 7660 sets |
Distribution | Nationwide
Foreign:
Canada
Australia
Denmark
Germany
New Zealand |
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 = DRO
|