Z-1554-2014 Class II Terminated
FDA device recall Z-1554-2014 was initiated by Bausch & Lomb Inc- Greenville Solutions Plant on April 21, 2014 and is designated Class II. Reason for recall: Out of specification results for one of the two disinfectants. The recall status is terminated (terminated January 9, 2015). Affected quantity: 256,440 bottles.
Recall Details
- Product Type
- Devices
- Report Date
- May 14, 2014
- Initiation Date
- April 21, 2014
- Termination Date
- January 9, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 256,440 bottles
Product Description
Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
Reason for Recall
Out of specification results for one of the two disinfectants.
Distribution Pattern
US Nationwide.
Code Information
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.