FDA Medical Device Recalls (openFDA)
Bausch & Lomb Inc- Greenville Solutions Plant: Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
- Recall number
- Z-1554-2014
- Recalling firm
- Bausch & Lomb Inc- Greenville Solutions Plant
- Product
- Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
- Status
- Terminated
- Initiated
- 2014-04-21
- Posted
- 2014-05-06
- Terminated
- 2015-01-09
- Reason
- Out of specification results for one of the two disinfectants.
- Root cause
- Nonconforming Material/Component
- Action
- Consignees were notified via registered mail starting 04/21/2014.
- Quantity
- 256,440 bottles
- Distribution
- US Nationwide.
- Lot, serial or model codes
- Lot GK2127 (twin packs), SKU: 623588, GK2131 (twin packs), SKU: 623500, STL2019, (6 pk shelf display containing GK2131, SKU: 629743 and STL2025 (6 pk shelf display containing GK2127), SKU: 629743.
- 510(k) numbers
- ["K083757"]
- PMA numbers
- not on file
- Product code
- LYL
- Firm FEI
- 1032500
- Firm city
- Greenville
- Firm state
- SC
- 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