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U.S. Department of Health and Human Services

Class 2 Device Recall CX9625 Light Pipe (25 Gauge).

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 Class 2 Device Recall CX9625 Light Pipe (25 Gauge).see related information
Date Initiated by FirmNovember 10, 2003
Date PostedDecember 24, 2003
Recall Status1 Terminated 3 on April 05, 2004
Recall NumberZ-0264-04
Recall Event ID 27714
510(K)NumberK940393 
Product Classification Transilluminator, Ac-Powered - Product Code HJM
ProductCX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes.
Code Information 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.
FEI Number 1317628
Recalling Firm/
Manufacturer		 Bausch & Lomb Inc
1400 Goodman St N
Rochester NY 14609-3547
For Additional Information ContactGlenn A. Davies
585-338-8215
Manufacturer 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 Determined
Cause 2		Other
ActionThe 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 Commerce2500 packs
DistributionThe 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = HJM
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