Z-0984-2017Class II

Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml)

Name: Z-0984-2017 Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml)
Creator: Medline Ind
Published: 2016-12-12
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2016-12-12 / Terminated / root cause: manufacturing process

FDA source

MEDLINE IND began a recall of Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to... on 2016-12-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0984-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-12
Posted: 2017-01-10
Terminated: 2019-06-27
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: KMJ Lubricant, Patient
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medline Industries sent a recall notification letters dated December 12, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to quarantine any affected product on hand and return product to Medline Industries for credit. Distributors were instructed to notify their customers and have them return affected product as well. For questions contact 866-359-1704.
Quantity in commerce: 12,024 tubes
Distribution: Worldwide Distribution - US Nationwide in the states of AL, FL, GA, IA, IL, IN LA, MI, PA, TX, WI, and the country of Canada
Product codes and lots: Lot Numbers: 6I26; Unit No: MDS032285; Expiration Date: 08/2019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0984-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0984-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-09

Product code KMJ

K041060Class IE-Z Lubricating JellyChester Labs, Inc. / cleared 2004-05-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)