| |
Class 2 Device Recall |
 |
| Date Initiated by Firm |
May 16, 2005 |
| Date Posted |
June 04, 2005 |
| Recall Status1 |
Terminated 3 on May 08, 2012 |
| Recall Number |
Z-0868-05 |
| Recall Event ID |
32079 |
| 510(K)Number |
K031057
|
| Product Classification |
Tube Tracheostomy And Tube Cuff - Product Code JOH
|
| Product |
Portex Per-Fit Percutaneous Dilational Tracheostomy Kit, ID 8.0mm
Product Number: 535080 |
| Code Information |
Lot Numbers: K515073, K515074, K515075, K518076, K518077, K520176, K523556, K527903, K548745, K559483, K614996, K630177 |
Recalling Firm/
Manufacturer |
Smiths Medical ASD, Inc.
10 Bowman Dr
Keene NH 03431-5043
|
| For Additional Information Contact |
Timothy Talcott
603-352-3812 Ext. 2457
|
Manufacturer Reason
for Recall |
Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
|
FDA Determined
Cause 2 |
Other |
| Action |
Smith Medical ASD initiated recall by letter on/about
about May 16, 2005.
|
| Distribution |
Natiowide
Foreign: Canada, Mexico and East Timor. |
| 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 = JOH and Original Applicant = PORTEX, INC.
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