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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker

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  Class 2 Device Recall Stryker see related information
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
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