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Recall Observatory FDA recall evidence

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

December 12, 2016

Class II

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

    reason.no_named_rule · v1.0.0

    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.