Sterile Lubricating Jelly Recall Issued by Triad Group

A recall has been announced for 18 lots of sterile lubricating jelly by Triad Group due to concerns that it may not be sterile. 

The Triad lubricating jelly recall was announced this week by the FDA. The sterile jelly, which was sold under a number of brand names, is typically used to provide easy insertion of a medical device or gloved fingers into body openings.

The recall affects Triad lubricating jelly packages sold in 5 gram, 2 ounce and 4 ounce tubes, 4 ounce bottles, as well as 3 and 5 gram packets. The jelly was sold under the brand names Allegiance, Select Medical Products, Novaplus, Triad, Triad Plus, IMCO, McKesson Medi-Pak Performance and Henry Schein.

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The jelly products were distributed by Triad between January 2007 and December 2010. In addition, they may have been packaged with kits, packs and trays by other firms after December 2010. A complete list of affected lot numbers is available on the FDA recall notice.

On December 22, Triad sent a letter to distributors by certified mail warning that they should immediately examine their inventory, quarantine the lubricating jelly products and notify their customers if they distributed the recalled products.

The FDA has instructed all medical device manufacturers and repackers who have used recalled products in kits, packs and trays to issue a sub-recall and submit recall strategies to the agency.

The recall comes a little more than a month after Triad announced a massive recall of alcohol prep pads, swabs and swab sticks used to clean injection sites.

The Triad alcohol swab recall was issued in early January, after the company discovered that the prep pads, swabs and swabsticks could be contaminated with Bacillus cereus. The Triad alcohol prep products were commonly used in hospitals and packaged with a number of medications. They were also sold under a variety of labels, including CVS, Walgreens and Cardinal Health.

Bacillus cereus is responsible for about two percent of all foodborne illness, according to the U.S. Centers for Disease Control and Prevention (CDC). Illness comes within 24 hours after exposure and can result in a diarrheal illness. Serious illness and permanent injury are very rare. It was not clear from the FDA recall if concerns about the jelly are related to Bacillus cereus fears involving Triad prep pads.

9 Comments

  • BethAugust 15, 2012 at 2:06 pm

    My husband & I used the Triad Lubricating Jelly. A few days later I had this terrible green discharge. When I went to the gynecologist she confirmed that I had a bacterial infection. I have never had this type of infection before and there is nothing else that could have caused it.

  • JosephMarch 29, 2012 at 7:47 pm

    I have had serious damage from lub jelly after changing, the test show I am okay now not even pills necessary Ive had Agreat deal of suffering and exspense and the infection totally stopped my sperm please dont say I cant prove this I can.

  • chrisJanuary 17, 2012 at 8:09 pm

    my husband has to cath himself 4 times a day and when we were notified that the lub had not been sterile for aprox 7 years we went to a lawyer, and they say we cannot do anything about it even though we have his medical records to prove he has has an excessive amount of uti and kidney infections he also has a plastic bladder so where did the bacteria come from

  • SophiaApril 7, 2011 at 11:25 pm

    During 2008 and 2009, my results from my annual pap smear came back abnormal. Each time I visited the doctor's office I always came down with a yeast infection 2 days later. I am not the type of person who gets yeast infections on a regular basis. I called them after getting another yeast infection on my 3rd visit and told them that I believed that perhaps their tools were not sterilized proper[Show More]During 2008 and 2009, my results from my annual pap smear came back abnormal. Each time I visited the doctor's office I always came down with a yeast infection 2 days later. I am not the type of person who gets yeast infections on a regular basis. I called them after getting another yeast infection on my 3rd visit and told them that I believed that perhaps their tools were not sterilized properly. They said that it wasn't the tools but it could be because I was under a lot of stress and that was causing it. I would have taken the stress into consideration except that these infections only came up after my visit to the obgyn. On my 4th visit, I looked in the doctor's drawer to see what type of lubricating jelly it was because I suspected that I was allergic to an ingredient in the lube. It was Triad. I had a total of 6 yeast infections that year. 2 were because the intial infection never fully went away. It was a very miserable year and my husband wasn't too happy either. Now that I read about the recall, I have no doubts that these infections were attributed to the lubricant. I stopped going to that particular obgyn and since then, I have never had another yeast infection.

  • KayMarch 26, 2011 at 3:50 am

    also my husband has loose bowels and stomach cramps I wonder if this jelly could have been behind all this He only used the jelly every 6 wks He as MD but I wouldn"t think the MD has anything to do with the constant loose bowels

  • KayMarch 24, 2011 at 6:00 am

    I have been using this jelly on my husband for a while now kind of scary wondering why he now keeps getting pneunmonia

  • RobertMarch 6, 2011 at 3:46 pm

    i have use triad libricating jelly all of 2010. I have had UTI most of the year been on antibiotics most of the year. My white cells were 100+ very high, also my urine had E_coli not very good. I have a very bad heart had advandce prostate cancer in 2007. So i know this cause me to have many health issues in 2010. Had trouble with my coumadin because of all the antibiotics i took. My distributo[Show More]i have use triad libricating jelly all of 2010. I have had UTI most of the year been on antibiotics most of the year. My white cells were 100+ very high, also my urine had E_coli not very good. I have a very bad heart had advandce prostate cancer in 2007. So i know this cause me to have many health issues in 2010. Had trouble with my coumadin because of all the antibiotics i took. My distributor knew this because every time i order my caths they would ask this question to you have UTi and the answer was allways yes. had to cath myself 10 t0 12 times a day because of Uti.

  • ThomasFebruary 24, 2011 at 3:28 am

    I, just today (2/23/11), found out about this recall by browsing the web even though it appears that a letter was sent to Triad distributors from the Triad Group over two months ago asking them to inform their customers of the recall. I purchased a substantial amount of "Triad" brand lubricating jelly for personal use on 9/11/2010. I have not been ill but I have experienced some unusual symptoms[Show More]I, just today (2/23/11), found out about this recall by browsing the web even though it appears that a letter was sent to Triad distributors from the Triad Group over two months ago asking them to inform their customers of the recall. I purchased a substantial amount of "Triad" brand lubricating jelly for personal use on 9/11/2010. I have not been ill but I have experienced some unusual symptoms related to the condition for which I use this product. I really feel violated on two counts. First by a manufacturer that does not seem to be concerned for the safety of its consumers and second by a distributor who has failed to notify me of this problem and, therefore, increased my potential for adverse effects from the product by denying me the information that would have caused me to discontinue its use.

  • MandyFebruary 17, 2011 at 12:33 pm

    I have worked at Triad. The left over "Jel products" are never discarded from the manufacturing vessle, harbouring microbes. Second batch of "Jel product" is manufactured on top of the other. The bioburden of the "Jel product" prior to gamma sterilization must be very high, to render sterilized products "non sterile".

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