Dri-Lok Disposable Cannula, Part numbers 3910-075-500, 3910-075-501, 3910-075-502, 3910-075-650, 3910-075-651, 3910-075-
FDA device recall Z-0868-2009 · posted 2009-01-16 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- Leak: Leak-resistant barrier may not properly seal and leak when an instrument is inserted, and keep leaking after instrument is removed.
- Action taken
- Recall initiated 12/01/2008, Sales representatives were notified via telephone and e-mail. Product advisories entitled ""Urgent: Device Removal" and dated December 1, 2008, were sent to all consignees. All unused product is to be returned to the firm. For further information, please contact Stryker Endoscopy by telephone at 408-754-2124.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 4,194 boxes (24,750 units)
- Distribution
- Worldwide Distribution --- including USA and countries of Australia, Brazil, Canada, Chile, China, France, Germany, Greece, India, Italy, New Zealand, Poland, Portugal, Sweden, Spain, Singapore, Switz
- Date initiated
- 2008-12-01
- Date posted
- 2009-01-16
- Date terminated
- 2011-01-10
- 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 |
|---|---|---|
| ARTHROSCOPE ACCESSORIES (K944210) | Stryker Endoscopy | 1995-02-14 |