The FDA is notifying healthcare professionals of a recall of Triad Group’s sterile lubricating jelly products because they may not be sterile. Patients who are immunocompromised (eg, those with diabetes, cancer, and certain other chronic diseases) may be at risk for infection. The affected Triad sterile lubricating jelly is packaged in 5g tubes, 2oz and 4oz tubes, 4oz bottles, and 3g and 5g packets.
The recall affects all lots beginning with the numbers 7, 8, 9, or 0. If the product is part of a kit, pack, or tray, the lot numbers will only appear on the lubricating jelly package itself. A list of the brand names under which the lubricating jelly is sold, distributors, and product identifiers can be found at: www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm243399.htm. Healthcare providers who have the recalled products in their possession should stop using them immediately.
Lubricating jelly products help to provide easy insertion of a medical device (eg, catheter or endoscope) or gloved fingers into body openings.
For more information call (262) 538-2900 ext. 2761 or visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm243552.htm.