Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0264-04

CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes

Bausch & Lomb Incorporated / initiated 2003-11-10 / Terminated

Bausch & Lomb Inc began a recall of CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes on . The reason FDA records is "The CX9625 Light Pipe connector may overheat; this condition could result in the plastic connector that plugs into the Millennium Microsurgical System to malfunction". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0264-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Bausch & Lomb Incorporated
Product
CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes.
Product code
HJM Transilluminator, Ac-Powered
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.
FDA 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 in commerce
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, China, Hong, Kong, India, Japan, Korea, Malaysia, Mexico, New Zealand, The Netherlands, Philippines, Singapore, Spain, Taiwan, and Thailand.
Product codes and lots
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.