Stryker Endoscopy, Infravision Esophageal Kit, Model Numbers: 220180548, 220180540, 220180560
FDA device recall Z-1002-2011 · posted 2011-02-01 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- The silicone sheath component of the product detaches from the catheter upon removal of the e-kit from the body.
- Action taken
- On 5/11/10, Stryker Endoscopy initiated the recall notification letters explaining the reason for the recall and requesting the product be returned.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FAT
- Quantity affected
- 4125
- Distribution
- Nationwide and 3 foreign consignees (Canada, Singapore and Switzerland).
- Date initiated
- 2010-05-11
- Date posted
- 2011-02-01
- Date terminated
- 2011-02-01
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER INFRAVISION ESOPHAGEAL KIT (K983220) | Stryker Endoscopy | 1999-06-04 |