Recall Z-1002-2011 ยท FAT Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Stryker Endoscopy
Stryker Endoscopy, Infravision Esophageal Kit, Model Numbers: 220180548, 220180540, 220180560
| Date | Feb 1, 2011 (initiated May 11, 2010) |
| Status | Terminated |
| Reason | The silicone sheath component of the product detaches from the catheter upon removal of the e-kit from the body. |
| Root cause | Device Design |
| Action | On 5/11/10, Stryker Endoscopy initiated the recall notification letters explaining the reason for the recall and requesting the product be returned. |
| Quantity | 4125 |
| Distribution | Nationwide and 3 foreign consignees (Canada, Singapore and Switzerland). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983220 | STRYKER INFRAVISION ESOPHAGEAL KIT Stryker Endoscopy, Jun 4, 1999 |