CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes.
FDA device recall Z-0264-04 · posted 2003-12-24 · Terminated
Recall details
- Recalling firm
- Bausch & Lomb Inc
- Reason for recall
- The CX9625 Light Pipe connector may overheat; this condition could result in the plastic connector that plugs into the Millennium Microsurgical System to malfunction.
- Action taken
- The recalling firm issued a recall notification dated 11/13/03 to their direct accounts. The recall notification explains the problem and return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- HJM
- Quantity affected
- 2500 packs
- Distribution
- The product was shipped to hospitals/medical facilities and physicians in AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NJ, NH, NY, NC, OH, PA, TN, TX, UT, VA, WA, WI, and WV
- Date initiated
- 2003-11-10
- Date posted
- 2003-12-24
- Date terminated
- 2004-04-05
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PEREGRINE WIDE ANGLE LIGHT PIPE (K940393) | Peregrine Surgical , Ltd. | 1994-09-02 |