Trach-Eze Closed Suction System Endotracheal Start Kit *** 16F *** REF 220070 *** Catheter Length: 571 mm *** STERILE **
FDA device recall Z-0496-03 · posted 2003-01-30 · Terminated
Recall details
- Recalling firm
- Sorenson Medical, Inc.
- Reason for recall
- Catheters have 2 unvalidated seal product configurations to produce a new hybrid seal that had not been verified or validated.
- Action taken
- On 10/25/2002, all consignees were notified by letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- BSY
- Quantity affected
- 2790 units
- Distribution
- Distributors in IL, OH, PA. Foreign distribution to Brazil, Czech Republic, Denmark, Guatemala, Italy.
- Date initiated
- 2002-11-25
- Date posted
- 2003-01-30
- Date terminated
- 2004-07-12
- Location
- West Jordan, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM (K961707) | Sorenson Critical Care | 1997-03-11 |