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U.S. Department of Health and Human Services

Class 2 Device Recall Medline EZ Lubricating Jelly

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  Class 2 Device Recall Medline EZ Lubricating Jelly see related information
Date Initiated by Firm December 12, 2016
Create Date January 10, 2017
Recall Status1 Terminated 3 on June 27, 2019
Recall Number Z-0984-2017
Recall Event ID 75948
510(K)Number K041060  
Product Classification Lubricant, patient - Product Code KMJ
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.
Code Information Lot Numbers: 6I26; Unit No: MDS032285; Expiration Date: 08/2019
Recalling Firm/
Manufacturer		 MEDLINE IND
3 Lakes Dr
Northfield IL 60093-2753
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KMJ and Original Applicant = CHESTER LABS, INC.
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