Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Dr. Sheffield's LUBRI GEL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Dr. Sheffield's LUBRI GELsee related information
Date Initiated by FirmApril 27, 2015
Date PostedJuly 02, 2015
Recall Status1 Terminated 3 on June 10, 2016
Recall NumberZ-1953-2015
Recall Event ID 71129
510(K)NumberK073684 
Product Classification Lubricant, vaginal, patient - Product Code MMS
ProductDr. 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
FEI Number 1210513
Recalling Firm/
Manufacturer		 Sheffield Pharmaceuticals, LLC
170 Broad St
New London CT 06320-5313
For Additional Information ContactJames 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
ActionA 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 Commerce37,636 pieces
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = MMS
-
-