StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070
FDA device recall Z-0279-06 · posted 2005-12-14 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- Devices for which sterility may be compromised as evidenced by a crack in the package.
- Action taken
- On 11/18/05, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.
- Root cause
- Other
- Status
- Terminated
- Product code
- GCX
- Quantity affected
- 48405 boxes, 6 units per box
- Distribution
- The product was distributed nationally to 1321 consignees and internationally to 18 consignees.
- Date initiated
- 2005-11-18
- Date posted
- 2005-12-14
- Date terminated
- 2006-11-02
- 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 CASSETTE PUMP (K042454) | Stryker Endoscopy | 2004-12-09 |