CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes.
This recall has been terminated (originally issued December 24, 2003).
- Company
- Bausch & Lomb Inc
- Recall Initiated
- November 10, 2003
- Posted
- December 24, 2003
- Terminated
- April 5, 2004
- Recall Number
- Z-0264-04
- Quantity
- 2500 packs
- Firm Location
- Rochester, NY
- Official Source
- View on FDA website ↗
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.
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, China, Hong, Kong, India, Japan, Korea, Malaysia, Mexico, New Zealand, The Netherlands, Philippines, Singapore, Spain, Taiwan, and Thailand.
Lot / Code Info
Lot numbers: 207089, 209102, 02121321, 02171838, 02192048, 02212272, 02222332, 02242552, 02262741, 02272856, 02293066, 02313269, 02323381, 02333458, 02363752, 02383927, 02404141, 02414225, 02424507, 02434421, 02434520, 02444529, 02454627, 02454672, 02464725, 02474823, 02484921, 02505121, 03020326, 03040522, 03040669, 03060728, 03060803, 03060865, 03080924, 03101124, 03111222, 03131428, 03151624, 03171820, 03171998, 03192023, 03212226, 03212370, 03232422, 03242537, 03252628, 03262726, 03303276, and 03303313.
Root Cause
Other
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.