Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201, 620-030-301
FDA device recall Z-1177-06 · posted 2006-06-27 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- Device for which sterility may be compromised as evidenced by a loss of package integrity.
- Action taken
- On 6/2/06, 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
- Packaging process control
- Status
- Terminated
- Product code
- HET
- Distribution
- Nationwide
- Date initiated
- 2006-06-02
- Date posted
- 2006-06-27
- Date terminated
- 2006-11-20
- 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 |
|---|---|---|
| INSUFFLATOR TUBING WITH FILTER (K943508) | Stryker Endoscopy | 1994-11-17 |