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.

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.