Recall Z-0264-04 ยท HJM Transilluminator, Ac-Powered
Bausch & Lomb Inc
CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes.
| Date | Dec 24, 2003 (initiated Nov 10, 2003) |
| Status | Terminated |
| Reason | The CX9625 Light Pipe connector may overheat; this condition could result in the plastic connector that plugs into the Millennium Microsurgical System to malfunction. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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. Nationwide. The product was also shipped to Puerto Rico, Argentina, Australia, Brazil, Canada, Ch |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K940393 | PEREGRINE WIDE ANGLE LIGHT PIPE Peregrine Surgical , Ltd., Sep 2, 1994 |