Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San Jose.
This recall has been terminated (originally issued December 28, 2010).
- Company
- Stryker Endoscopy
- Recall Initiated
- August 20, 2009
- Posted
- December 28, 2010
- Terminated
- January 3, 2011
- Recall Number
- Z-0830-2011
- Quantity
- 2985 units
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body.
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.
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
Root Cause
Device Design
Action Taken
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.