Device recall enforcement reports

Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate bo…

MEDLINE IND · Product was not sterilized. Product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shippin…

Class IITerminatedZ-0984-2017
Country
United States
City
Northfield
Address 1
3 Lakes Dr
Product quantity
12,024 tubes
Code info
Lot Numbers: 6I26; Unit No: MDS032285; Expiration Date: 08/2019
Center classification date
20170109
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
State
IL
Report date
20170118
Classification
Class II
Recalling firm
MEDLINE IND
Recall number
Z-0984-2017
Initial firm notification
Letter
Product type
Devices
Event ID
75948
Termination date
20190627
Recall initiation date
20161212
Postal code
60093-2753
Voluntary mandated
Voluntary: Firm initiated
Status
Terminated
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.

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.

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.