Triad Group is recalling lubricating jelly products sold under the brand names Allegiance, Select Medical Products, Novaplus, Triad, Triad Plus, IMCO, McKesson Medi-Pak Performance, and Henry Schein because of possible sterility issues. Triad Group is the same manufacturer that recently recalled alcohol prep pads, alcohol swabs, and alcohol swabsticks sold under a variety of brand names because of concerns over bacterial contamination.
The Triad lubricating jelly products help to provide easy insertion of a medical device (such as a catheter or an endoscope) or gloved fingers into body openings. The lubricating jelly was distributed by Triad from January 2007 through December 2010, however, these products may be contained in kits, packs, or trays that have been packaged after December 2010 by other firms.
A complete list of the products affected by Triad lubricating jelly recall can be found here.
According to the recall notice, these products may not be sterile. Patients who are immuno-compromised, such as those with diabetes, cancer and certain other chronic diseases, may be at potential risk for infection.
On December 22, 2010, the company sent an “Urgent Medical Device Recall” letter to all its customers by certified mail. The letter described the issue, identified the affected products, and the action to be taken by the customers.
The U.S. Food & Drug Administration (FDA) is instructing manufacturers and repackers who have incorporated the recalled products into their kits, packs or tray to promptly submit a sub-recall of the affected products.
In January, Triad Group issued a recall of alcohol prep pads, alcohol swabs, and alcohol swabsticks because of potential contamination with the bacteria Bacillus cereus. Those products can be identified by either “Triad Group,” listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin. The recall affected products marked as STERILE as well as non-sterile products.
Earlier this week, the parents of a toddler named Triad Group in wrongful death lawsuit after their child died from acute bacterial meningitis following what was supposed to be the routine surgical removal of a benign cyst near his brain. According to the lawsuit, sterile alcohol pads made by Triad Group were used in the surgery, and the family has alleged negligence on the part of the company.