FDAFDA · Food and drugs·Recall number Z-0984-2017
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.
Published January 18, 2017 · Recall initiated: December 12, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE IND
- Distributor
- Worldwide Distribution - US Nationwide in the states of AL, FL, GA, IA, IL, IN LA, MI, PA, TX, WI, and the country of Canada
- Lot
- Lot Numbers: 6I26; Unit No: MDS032285; Expiration Date: 08/2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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