Z-0984-2017 Class II Terminated
FDA device recall Z-0984-2017 was initiated by MEDLINE IND on December 12, 2016 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated June 27, 2019). Affected quantity: 12,024 tubes.
Recall Details
- Product Type
- Devices
- Report Date
- January 18, 2017
- Initiation Date
- December 12, 2016
- Termination Date
- June 27, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,024 tubes
Product Description
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.
Reason for Recall
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.
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
Code Information
Lot Numbers: 6I26; Unit No: MDS032285; Expiration Date: 08/2019