Urgent Medical Device Recall: Triad Group Recalls Sterile Lubricating Jelly

Professional Medical, Inc. recently received notice from the Triad Group regarding an URGENT MEDICAL DEVICE RECALL. The product being recalled is STERILE LUBRICATING JELLY manufactured by the Triad Group and distributed by a number of companies, including Professional Medical.

This recall has been initiated due to concerns expressed by the Food and Drug Administration (FDA) regarding the validation of the gamma radiation sterilization cycles for the Sterile Lubricating Jelly. The use of inadequately sterilized product might result in patient infection.

This recall extends to all lots of Sterile Lubricating Jelly remaining within their labeled expiration dating (three years), including all lot numbers beginning with the digits 7, 8 and 9 and 0. These product lots began shipping in January of 2007.

Please examine all storage rooms, med rooms, med carts and treatment carts and inform nurses to be aware of all insertion kits that might contain lubricating jelly.

Affected items might be listed under the following three item numbers from ProMed:
• 500-LJ04
• 500-LJ144-3GM
• 500-LJ12-04FT

Whether you have the product subject to recall in your possession or not, please take the following steps:
1. Quarantine the affected product, if applicable
2. Email Pam West, VP of Clinical and Regulatory Compliance, at pwest@promedsupply.com for a Product Recall Acknowledgement Form.

If product is needed immediately, a replacement product (065-20545) is available from another manufacturer. Please note there is a difference in price.

We apologize for any inconvenience this might cause you and your staff. Please be assured that we are here to help. If you have any questions, please contact the Customer Relations Department at 800-648-5190.