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U.S. Department of Health and Human Services

Class 2 Device Recall Dr. Sheffield's LUBRI GEL

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  Class 2 Device Recall Dr. Sheffield's LUBRI GEL see related information
Date Initiated by Firm April 27, 2015
Date Posted July 02, 2015
Recall Status1 Terminated 3 on June 10, 2016
Recall Number Z-1953-2015
Recall Event ID 71129
510(K)Number K073684  
Product Classification Lubricant, vaginal, patient - Product Code MMS
Product Dr. Sheffield's LUBRI GEL 3 oz (85 g)

Non sterile over-the-counter personal lubricant.
Code Information Lot Numbers: 40131 EXP 01/18 ; 40132 EXP 01/18; 40141 EXP 01 /18
Recalling Firm/
Manufacturer		 Sheffield Pharmaceuticals, LLC
170 Broad St
New London CT 06320-5313
For Additional Information Contact James Turner
800-222-1087
Manufacturer Reason
for Recall		 Recovery of high count of gram positive rods including single colonies of B. cepacia.
FDA Determined
Cause 2		 Process control
Action A letter was sent to inform customers of the voluntary recall of Sheffield Pharmaceuticals Lubri-Gel Personal Lubricant Jelly. The letter described the issue and asked customers to quarantine all related inventory immediately and provide their inventory counts on the specific lots. Questions or concerns related to the recall or letter can be directed to James Turner at James.Turner@sheffield-pharmaceuticals.com.
Quantity in Commerce 37,636 pieces
Distribution Worldwide Distribution -- CA, NJ, FL, PR, NJ, MI, NY, NC, FL, IL, GA, MN, KS, and NC; and, the countries of Jamaica and Georgia.
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 = MMS and Original Applicant = SHEFFIELD INDUSTRIES, DIV. OF FARIA LTD.
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