WASHINGTON -- The FDA listed a recall of a "sterile" lubricating jelly as Class II due to the product's potential lack of sterility.
The jelly -- which was included in a number of kits, packs, and trays under several brand names -- may pose an infection risk in patients who are already immunocompromised, an FDA statement said.
The Triad Group issued a voluntary recall of Triad Sterile Lubricating Jelly in 5-g tubes, 2- and 4-oz tubes, 4-oz bottles, and 3- and 5-g packets on Dec. 23, 2010.
The product was included in product packages from Allegiance, Select Medical Products, Novaplus, Triad, Triad Plus, IMCO, McKesson Medi-Pak Performance, and Henry Schein, the statement said.
Affected lubricant packs included in the branded products and otherwise have lot numbers beginning with 7, 8, 9, or 0. Kits, packs, and trays packaged with the lubricant will have the lot number listed on the pack.
The affected products were distributed from January 2007 to December 2010, though products containing the recalled jelly may have been packed and distributed after December 2010.
T&P Industries, parent of Triad Group, issued an urgent medical device recall notice on Dec. 22, 2010, which identified affected product and requested distributors and kit manufacturers that have the nonsterile lubricant to:
- Examine available inventory
- Quarantine lubricating jelly products
- Notify customers if the recalled jelly was distributed
- Return any available recalled product
The FDA added to the company recall that any subdistributors should contact customers to alert them of the lubricant recall.
Class II recalls affect products that may cause temporary or medically reversible adverse events or that have a remote probability of causing death with use.