Recalls / —
—#43142
Product
StrykeFlow II Disposable Suction/Irrigator; AHTO Tube Set; Model Numbers: 250-070-500, 250-070-520, 250-070-540, 250-070-600, 250-070-620; Product is distributed by Stryker Endoscopy, 5900 Optical Court San Jose, CA 95138
- FDA product code
- GCX — Apparatus, Suction, Operating-Room, Wall Vacuum Powered
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K042454
- Affected lot / code info
- Lots 05258FG2 through 05299FG2; ***On 1/6/06 Lot Code bracket expanded: 05151FG2 through 05299FG2***
Why it was recalled
Devices for which sterility may be compromised as evidenced by a crack in the package.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Stryker Endoscopy
- Address
- 5900 Optical Ct, San Jose, California 95138
Distribution
- Distribution pattern
- The product was distributed nationally to 1321 consignees and internationally to 18 consignees.
Timeline
- Recall initiated
- 2005-11-18
- Posted by FDA
- 2005-12-14
- Terminated
- 2006-11-02
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #43142. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.