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

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


New Search Back to Search Results
 Class 2 Recall
Water Soluble Lubricant		see related information
Date Posted April 18, 2011
Recall Number Z-2013-2011
Product Lubricating Jelly packaged as follows: (1) DeRoyal(R) Water Soluble Lubricant, Size: 5 Gram, Rx Only, REF 31-702, STERILE EO, Distributed by: DeRoyal - 200 DeBusk Lane, Powell, TN 37849, USA; (2) DeRoyal(R) Water Soluble Lubricant, 1 / Pack, Size: 2 oz Rx Only, REF 31-704, STERILE EO, Distributor: DeRoyal, 200 DeBusk Lane, Powell, TN 37849, USA; (3) DeRoyal(R) Lubricant, Size: 5 Gram, Rx Only, REF 31-938, STERILE EO, Distributed by: DeRoyal - 200 DeBusk Lane, Powell, TN 37849, USA Lubricating body orifices.
Code Information 31-702: 18040107, 18125741, 18150322, 18368014, 18605067, 18605067, 19032694, 19032694, 19136741, 19557491, 20023453, 20102637, 20190729, 20190729, 20023453, 20190729, 20510139, 20023453, 20190729, 21049840, 21049840, 21517201, 21780683, 21780683, 21517201, 21780683, 22025604, 22147169, 21517201, 21517201, 22269799, 22952133, 23474014, 23474014, 23474014, 24194532, 24194532, 24406620, 17950117, 19136741, 21517201, 21780683, 22147169, 22025604, 22595121, 23918771, 24406620, 20190729, 18040107, 18605067, 19032694, 19136741, 20190729, 18150322, 19032694, 20102637, 20190729, 20190729, 21517201, 22269799, 22269799, 24406620, 24406620, 17296856, 17950117, 18368014, 18368014, 18368014, 18605067, 19557491, 19557491, 20510139, 20634166, 21168988, 22952133, 22595121, 22898042, 22952133, 22269799, 24194532, 24194532, 24406620, 19557491, 19032694, 19032694, 20023453, 20023453, 20190729, 20510139, 20634166, 21517201, 21517201, 21517201, 22898042, 21517201, 23918771, 18040107, 18605067, 20023453, 20634166, 21049840, 21168988, 21517201, 22595121, 17950117, 17296856, 19136741, 19032694, 20190729, 20190729, 20190729, 20190729, 20190729, 20023453, 20634166, 21517201, 22025604, 21517201, 21517201, 23918771, 17950117, 18040107, 18368014, 18605067, 18605067, 19032694, 19218034, 19136741, 19557491, 20190729, 20190729, 20190729, 20510139, 21049840, 21049840, 21517201, 21780683, 22025604, 21517201, 21517201, 21517201, 21517201, 22952133, 22595121, 21517201, 23918771, 23474014, 24194532, 23474014, 24892314, 24194532, 22025604, 18040107, 18125741, 18368014, 18605067, 19032694, 19136741, 19218034, 20023453, 20102637, 20190729, 20190729, 20510139, 20634166, 21168988, 21517201, 21588464, 21517201, 20634166, 21517201, 21780683, 22025604, 22595121, 21517201, 22269799, 23474014, 24194532, 24194532, 20023453, 20190729, 20634166, 22595121, 22898042, 21517201, 23474014, 24641355 31-704: 17407430, 18395135, 18605075, 18605075, 19476391, 19476391, 19557520, 20510155, 20914037, 21049866, 21238801, 1397561, 21588481, 21746987, 22269810, 23474022, 23474022, 23750736, 23750736, 24406638, 24406638, 24406638, 17407430, 17407430, 17407430, 17950133, 18234024, 18395143, 18368031, 18368031, 18368031, 18605075, 18962021, 18962021, 18605075, 18962021, 18605075, 18962021, 18605075, 19089121, 19089121, 19476391, 19476391, 19476391, 19476391, 19792802, 19792802, 19557520, 19792802, 19557520, 19792802, 20510155, 20510155, 20510155, 20656576, 20656576, 20656576, 20914037, 20510155, 20656576, 20914037, 21049866, 20656576, 21049866, 21049866, 21238801, 21238801, 21397561, 21588481, 21588481, 21588481, 21746987, 21746987, 21746987, 22037111, 22037111, 22269810, 22531646, 22531646, 22531646, 22758218, 22758218, 22758218, 22269810, 23192682, 23192682, 23474022, 23474022, 23750736, 23474022, 23750736, 24175892, 24175892, 24175892, 24406638, 24406638, 24406638, 24764187, 17950133, 18234024, 18368031, 18368031, 18368031, 18605075, 18605075, 18962021, 18962021, 19089121, 19089121, 19476391, 19792802, 19557520, 19557520, 20510155, 20656576, 20656576, 20656576, 21049866, 21238801, 21238801, 21397561, 21397561, 21588481, 21746987, 21746987, 22037111, 22037111, 22269810, 22531646, 22758218, 22269810, 23474022, 23750736, 23750736, 23750736, 24175892, 23750736, 24175892, 24175892, 24175892, 24175892, 24406638, 24175892, 24175892, 24406638, 24406638, 24764187, 22269810, 18962021, 17407430, 18234024, 18234024, 18368031, 18395135, 18605075, 18962021, 19089121, 19089121, 19476391, 19476391, 19792802, 17407430, 18234024, 19089121, 18605075, 19476391, 20510155, 20656576, 21397561, 21588481, 21588481, 21746987, 22531646, 22758218, 22269810, 22269810, 23192682, 23474022, 23192682, 23474022, 24406638, 24764187, 18605075, 19089121, 19476391, 19557520, 19792802, 20510155, 20914037, 21049866, 21049866, 21049866, 21238801, 23750736, 24406638, 24406638, 24406638, 23192682, 18962021, 21049866, 21588481, 23750736, 17407430, 17950133, 18234024, 18234024, 20510155, 21049866, 21238801, 21746987, 22037111, 20914037, 18605075, 23474022, 22758218, 17407430, 17407430, 17407430, 17950133, 17950133, 18234024, 18368031, 18368031, 18605075, 18962021, 18962021, 19089121, 19089121, 18605075, 18962021, 18605075, 18962021, 19476391, 19476391, 19476391, 19476391, 19792802, 19792802, 19557520, 19792802, 20510155, 20510155, 19557520, 20510155, 20656576, 20656576, 20914037, 20914037, 20656576, 20656576, 21049866, 21049866, 21506318, 21746987, 21746987, 22037111, 22037111, 22269810, 22758218, 22758218, 22758218, 22269810, 22269810, 23192682, 23192682, 23192682, 23474022, 23474022, 23474022, 23474022, 23474022, 23474022, 23750736, 23750736, 24175892, 24175892, 24406638, 24406638, 24406638, 24764187, 24406638, 21397561, 22269810, 23474022, 23750736, 24175892, 24764187, 19792802, 17407430, 17950133, 18234024, 18395143, 18368031, 18605075, 18962021, 18962021, 19089121, 19089121, 18605075, 19476391, 19476391, 19792802, 19792802, 19557520, 19557520, 19792802, 20510155, 20510155, 20510155, 20510155, 20656576, 20656576, 20656576, 20914037, 20656576, 21238801, 21506318, 21397561, 21397561, 21588481, 21397561, 22037111, 22531646, 22531646, 22758218, 22269810, 22269810, 22269810, 23192682, 23192682, 23192682, 23192682, 23474022, 23474022, 23474022, 23750736, 23474022, 23750736, 23750736, 24175892, 24175892, 23750736, 24406638, 24406638, 24406638, 24406638, 24764187, 23192682, 17407430, 18605075, 18605075, 18605075, 19476391, 19476391, 20510155, 20914037, 21506318, 21588481, 22037111, 22758218, 22269810, 23474022, 23750736, 24175892, 24764187, 17950133, 18234024, 18368031, 18234024, 18605075, 19089121, 19089121, 18605075, 19476391, 1792802, 19557520, 20510155, 20510155, 20510155, 20914037, 21238801, 21238801, 21506318, 21397561, 21588481, 21746987, 21746987, 21746987, 22037111, 22269810, 22531646, 22758218, 22269810, 22758218, 22269810, 22531646, 23192682, 23192682, 23750736, 23750736, 24175892, 24175892, 24764187, 18605075, 17950133, 17950133, 18395143, 18368031, 18962021, 18605075, 19089121, 18605075, 19476391, 18605075, 19557520, 19557520, 20510155, 20510155, 20656576, 20656576, 20656576, 21238801, 21397561, 21588481, 21746987, 22269810, 22531646, 22758218, 22269810, 23192682, 23474022, 23750736, 24406638, 24406638, 24406638, 24764187, 19476391, 21049866, 22037111, 17950133, 18395143, 18368031, 18605075, 17950133, 18368031, 18605075, 19089121, 19476391, 19557520, 20510155, 20656576, 21238801, 21397561, 21588481, 21746987, 22037111, 22758218, 22758218, 23192682, 23750736, 24175892, 24406638, 18605075, 20510155, 20510155, 20656576, 21049866, 21049866, 21746987, 21746987, 22269810, 23192682, 23192682, 24406638, 17950133, 18368031, 18605075, 19792802, 20510155, 20914037, 21049866, 21397561, 21588481, 21588481, 21588481, 22269810, 23192682, 23192682, 23192682, 23474022, 23750736, 24175892, 24175892, 24406638, 24764187, 24764187, 18234024, 18234024, 18234024, 18234024, 18962021, 19089121, 19476391, 19476391, 19557520, 19557520, 20510155, 20510155, 20510155, 22758218, 23750736, 19476391, 19089121, 19476391, 19089121, 19476391, 20510155, 20510155, 20656576, 21238801, 18605075, 22531646, 22758218, 20656576, 22037111, 17407430, 17950133, 18395143, 18234024, 18368031, 18368031, 18605075, 18605075, 18605075, 18605075, 18605075, 18962021, 19089121, 18962021, 18605075, 18605075, 19476391, 19476391, 19089121, 19792802, 19557520, 19557520, 20510155, 20510155, 20510155, 20510155, 20914037, 20914037, 18234024, 20656576, 20914037, 21049866, 21049866, 20656576, 21049866, 21238801, 21238801, 21397561, 21397561, 21397561, 21746987, 21746987, 21746987, 22037111, 22269810, 22531646, 22531646, 22531646, 22758218, 22758218, 22269810, 22269810, 22269810, 23192682, 23192682, 23474022, 23474022, 23474022, 23750736, 23750736, 23750736, 23750736, 23750736, 24175892, 24175892, 24406638, 24406638, 24406638, 24406638, 24764187, 17407430, 23192682, 23474022, 24175892, 24175892, 21397561, 21588481, 21746987, 22037111, 22037111, 22269810, 22269810, 22269810, 22531646, 22269810, 23474022, 24406638, 24764187, 24406638, 24764187, 17407430, 18234024, 18368031, 18395135, 18395135, 18605075, 18605075, 18962021, 18962021, 18962021, 18962021, 19089121, 19089121, 19476391, 19476391, 19792802, 20510155, 20510155, 20656576, 20656576, 20656576, 21238801, 21397561, 21506318, 17950133, 17950133, 17950133, 18234024, 18368031, 18605075, 18605075, 18605075, 18962021, 18962021, 19089121, 19089121, 18605075, 19476391, 19476391, 19792802, 19557520, 19557520, 20510155, 20510155, 20510155, 20656576, 20914037, 20914037, 24406638, 24764187, 18962021, 19476391, 19792802, 19792802, 20510155, 20656576, 21588481, 21746987, 22037111, 22531646, 23192682, 23474022, 23750736, 18234024, 19476391, 21238801, 22037111, 23192682, 24175892, 21397561, 21746987, 22531646, 22269810, 23474022, 24175892, 21049866 31-938: 18368057, 17070224, 17407448, 17407448, 18368057, 20656584, 21588499, 22147193, 20510180, 21747007, 24194559, 18500214, 20656584, 22269836, 23750744, 21747007, 24046927, 24194559, 24406646, 20069646, 21672797, 21672797, 18368057, 24406646, 17407448, 17407448, 18368057, 18500214, 18500214, 18500214, 19089148, 19089148, 19089148, 19089148, 19089148, 18500214, 20069646, 19940879, 20069646, 20510180, 20656584, 20656584, 20656584, 20069646, 20510180, 21672797, 21747007, 21747007, 21907509, 22147193, 22269836, 21907509, 22269836, 22853565, 21747007, 21907509, 23382419, 23750744, 24046927, 24194559, 24406646, 24194559, 17407448, 18500214, 18500214, 19089148, 20069646, 19940879, 20656584, 21672797, 22269836, 23750744, 19089148, 20656584, and 22269836.
Recalling Firm/
Manufacturer		 DeRoyal Processing Center
1703 Highway 33 S
New Tazewell, Tennessee 37825-5043
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Mr. Tracy Edmundson
865-362-2334
Reason for
Recall		 Possible contamination due to sterilization issue. Inspection of contract manufacturer found cGMP deficiencies.
Action The firm notified their consignees by a Re: DeRoyal Recall Of Triad Group Lubricating Jelly letter, dated Friday, March 18,2011. The letter discussed the reason for recall and the affected products. The letter asked customers to identify inventory using the attached spreadsheet and quarantine to prevent further use. Customers are to complete the spreadsheet regardless if they have effected product or not. The completed form can be faxed to 865-362-3716 or emailed to recalls@deroyal.com. All affected products should be return to DeRoyal at the address provided. Distributors are to forward a copy of the notice to their end-users. If there are questions or assistance is needed with the recall, Stephanie DeBusk should be contacted at 865-362-1037 or Sharon Cook at 865-362-6157.
Quantity in Commerce 323,440 units
Distribution Nationwide Distribution
 
-
-