| Date Initiated by Firm | September 02, 2005 |
|---|
| Date Posted | November 02, 2005 |
|---|
| Recall Status1 |
Terminated 3 on January 17, 2011 |
| Recall Number | Z-0116-06 |
|---|
| Recall Event ID |
33327 |
| 510(K)Number | K012274 |
|---|
| Product Classification |
Dc-Defibrillator, Low-Energy, (Including Paddles) - Product Code LDD
|
| Product | QUIK-COMBO pacing/defibrillation/ECG (therapy) cables used with the LIFEPAK 12 defibrillator/monitor series. |
|---|
| Code Information |
Cables do not contain serial numbers. Therapy cable part number: 3006570-006 and below |
| FEI Number |
3015876
|
Recalling Firm/
Manufacturer |
Medtronic Emergency Response Systems, Inc.
11811 Willows Rd Ne
Redmond WA 98052-2003
|
| For Additional Information Contact | John A. Parks
425-867-4681 |
|---|
Manufacturer Reason
for Recall | Potential for voltage pins in connector of therapy cable to break. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | On 9/2/05 the firm issued letters dated September 2005 to their customers. The letters state the problem, advise the cables and/or connectors will be replaced, and emphasize daily inspection and testing, |
|---|
| Quantity in Commerce | total for both types - 52,654 |
|---|
| Distribution | Devices were distributed worldwide. |
|---|
| 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 = LDD
|
|---|
