Recall Z-0830-2011 ยท FAT Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Stryker Endoscopy
Stryker Infravision Esophageal Kit, Model Numbers 220180548, 220180540, 220180560, manufactured by Stryker Endoscopy San Jose.
| Date | Dec 28, 2010 (initiated Aug 20, 2009) |
| Status | Terminated |
| Reason | The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body. |
| Root cause | 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 | 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, N |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983220 | STRYKER INFRAVISION ESOPHAGEAL KIT Stryker Endoscopy, Jun 4, 1999 |