Device product
Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
Z-1953-2015
Product summary
- Event
- Event 71129
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37,636 pieces
- Official record key
device-enforcement:Z-1953-2015
Official wording
Reason: Recovery of high count of gram positive rods including single colonies of B. cepacia.
Code information: Lot Numbers: 40131 EXP 01/18 ; 40132 EXP 01/18; 40141 EXP 01 /18
Distribution pattern: Worldwide Distribution -- CA, NJ, FL, PR, NJ, MI, NY, NC, FL, IL, GA, MN, KS, and NC; and, the countries of Jamaica and Georgia.
Derived failure modes
-
Unknown
Recovery of high count of gram positive rods including single colonies of B. cepacia.