Recall Z-0984-2017— MEDLINE IND

Name: FDA recall Z-0984-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-12

Class II · Terminated

Class II FDA medical device recall by MEDLINE IND, initiated 2016-12-12, terminated 2019-06-27. It names one FDA 510(k) clearance: K041060. 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.. 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..

Recalling firm: MEDLINE IND
Classification: Class II
Status: Terminated
Initiated: 2016-12-12
Terminated: 2019-06-27
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K041060 — E-Z LUBRICATING JELLYChester Labs, Inc.·cleared 2004-05-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.