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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 Strykersee related information
Date Initiated by FirmJune 02, 2006
Date PostedJune 27, 2006
Recall Status1 Terminated 3 on November 20, 2006
Recall NumberZ-1177-06
Recall Event ID 35610
510(K)NumberK943508 
Product Classification Laparoscope, Gynecologic (And Accessories) - Product Code HET
ProductStryker 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
FEI Number 2936485
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
ActionOn 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.
DistributionNationwide
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HET
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