Date Initiated by Firm |
June 02, 2006 |
Date Posted |
June 27, 2006 |
Recall Status1 |
Terminated 3 on November 20, 2006 |
Recall Number |
Z-1177-06 |
Recall Event ID |
35610 |
510(K)Number |
K943508
|
Product Classification |
Laparoscope, Gynecologic (And Accessories) - Product Code HET
|
Product |
Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set,
Model Numbers: 620-030-201, 620-030-301
|
Code Information |
Lots 04051142--06121FE2, 04051142--06123FE2 |
Recalling Firm/ Manufacturer |
Stryker Endoscopy 5900 Optical Ct San Jose CA 95138
|
Manufacturer Reason for Recall |
Device for which sterility may be compromised as evidenced by a loss of package integrity.
|
FDA Determined Cause 2 |
Packaging process control |
Action |
On 6/2/06, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned. |
Distribution |
Nationwide |
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 = HET and Original Applicant = Stryker Endoscopy
|