| Date Initiated by Firm | January 02, 2007 |
|---|
| Date Posted | March 16, 2007 |
|---|
| Recall Status1 |
Terminated 3 on December 05, 2007 |
| Recall Number | Z-0637-2007 |
|---|
| Recall Event ID |
37102 |
| 510(K)Number | K950118 |
|---|
| Product Classification |
Catheter - Product Code FOZ
|
| Product | COOK Triple Lumen Central Venous Catheter Tray with Cook Spectrum Glide Antimicrobial Catheter with EZ--Pass Hydrophilic Coating: Reorder Number C-UTLMY-701J-RSC-ABRM-HC-FST-A. |
|---|
| Code Information |
Lots 1794998 and 1793611. |
| FEI Number |
1820334
|
Recalling Firm/
Manufacturer |
Cook, Inc.
750 Daniels Way
Bloomington
IN
47404-9120
|
| For Additional Information Contact |
800-346-2626 |
|---|
Manufacturer Reason
for Recall | These catheters do not include the proximal sidehole as required by the specification. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were notified by phone on 1/2/07 and instructed to return the product. |
|---|
| Quantity in Commerce | 100 |
|---|
| Distribution | Nationwide, including the states of Florida, Louisiana, Maine, Massachusetts, Minnesota, Missouri, New Jersey and North Carolina. |
|---|
| 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 = FOZ
|
|---|
