—#84866

Product

Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San Jose.

FDA product code: FAT — Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K983220
Affected lot / code info: 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

Why it was recalled

The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Stryker Endoscopy
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-08-20
Posted by FDA: 2010-12-28
Terminated: 2011-01-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84866. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.