Recall Z-1026-2011 ยท LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
Bausch & Lomb Inc
Up&Up Multipurpose Solution, no-rub formula, 12 FL OZ (355 mL), Sterile, Distributed by Target Corporation, Minneapolis, MN 55403 Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses.
| Date | Feb 2, 2011 (initiated Dec 22, 2010) |
| Status | Terminated |
| Reason | There is a potential for some packages to not meet sterility requirements. |
| Root cause | Other |
| Action | On December 8, 2010, Target was visited by FDA/PHI-DO and was informed on the violation. The Target customers that received lot GH0078 were requested to return all affected product directly to the Bausch & Lomb Greenville, SC Distribution Center. Bausch and Lomb sent an Urgent Voluntary Medical Device Recall to all first consignees who were shipped the affected lot GH0066 of Renu Fresh Multipurpose Solution on/about December 22, 2010. Since Target customers had already been notified previously regarding lot GH0078, this lot number was not included in the subsequent recall notification. All con |
| Quantity | 67,296 12 oz Bottles (33,648 twin packs) |
| Distribution | Worldwide Distribution - USA including AL, CA, CT, FL, GA, HI, IA, IN, LA, MA, MI, NE, NJ, NY, OH, PA, RI, SC, TN, TX, UT, VA, and WI and the countries Taiwan and Brazil |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.