FDA Medical Device Recalls (openFDA)
Bausch & Lomb Inc: CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes.
- Recall number
- Z-0264-04
- Recalling firm
- Bausch & Lomb Inc
- Product
- CX9625 Light Pipe (25 Gauge). The product is sold in packs containing six pipes.
- Status
- Terminated
- Initiated
- 2003-11-10
- Posted
- 2003-12-24
- Terminated
- 2004-04-05
- 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, China, Hong, Kong, India, Japan, Korea, Malaysia, Mexico, New Zealand, The Netherlands, Philippines, Singapore, Spain, Taiwan, and Thailand.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K940393"]
- PMA numbers
- not on file
- Product code
- HJM
- Firm FEI
- 1317628
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28