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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Infravision Esophageal Kit

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  Class 2 Device Recall Stryker Infravision Esophageal Kit see related information
Date Initiated by Firm August 20, 2009
Date Posted December 28, 2010
Recall Status1 Terminated 3 on January 03, 2011
Recall Number Z-0830-2011
Recall Event ID 53183
510(K)Number K983220  
Product Classification Bougie, esophageal, and gastrointestinal, gastro-urology - Product Code FAT
Product Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San Jose.
Code Information 5687,5766,5815,5822,5833,5872, 5924,60973888,60987814, 61004943, STROll409-l, STROl1409-2, STRO 11609-1, STROl1609-2, STR02l009-1, STR02l009-8, STR022709-l, STR022709-2, STR03ll09-1, STR03ll09-3, STR040l09-l, STR041709-2, STR041709-4, STR0430009-2, STRlO0208-l, STR102208-1, STR102408-l, STRI02708-7, STR103l08-1, STRlll308-l, STR12l808-l, STR12l808-2, STROl1209-l  
Recalling Firm/
Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact Nila Patel
Manufacturer Reason
for Recall
The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body.
FDA Determined
Cause 2
Device Design
Action Stryker issued Urgent Product Recall letters dated August 20, 2009 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were requested to return the affected product to Styrker.
Quantity in Commerce 2985 units
Distribution Worldwide Distribution: USA in the states of: Alabama, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia, and Wyoming, and the countries/region of Australia, Canada, Scandinavia, Italy, and Switzerland.
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 = FAT and Original Applicant = Stryker Endoscopy