Device product
Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
Z-0984-2017
Product summary
- Firm
- MEDLINE IND
- Event
- Event 75948
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,024 tubes
- Official record key
device-enforcement:Z-0984-2017
Official wording
Reason: Product was not sterilized. Product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shipping company.
Code information: Lot Numbers: 6I26; Unit No: MDS032285; Expiration Date: 08/2019
Distribution pattern: Worldwide Distribution - US Nationwide in the states of AL, FL, GA, IA, IL, IN LA, MI, PA, TX, WI, and the country of Canada
Derived failure modes
-
Unknown
Product was not sterilized. Product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shipping company.