Recalls / —
—#46467
Product
Stryker brand Insufflation Tube Set and High Flow Insufflation Tube Set, Model Numbers: 620-030-201, 620-030-301
- FDA product code
- HET — Laparoscope, Gynecologic (And Accessories)
- Device class
- Class 2
- Medical specialty
- Obstetrics/Gynecology
- 510(k) numbers
- K943508
- Affected lot / code info
- Lots 04051142--06121FE2, 04051142--06123FE2
Why it was recalled
Device for which sterility may be compromised as evidenced by a loss of package integrity.
Root cause (FDA determination)
Packaging process control
Action the firm took
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.
Recalling firm
- Firm
- Stryker Endoscopy
- Address
- 5900 Optical Ct, San Jose, California 95138
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2006-06-02
- Posted by FDA
- 2006-06-27
- Terminated
- 2006-11-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #46467. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.