Regard, T AND A - Rogers, sterilized convenience kits

Kits lacks rubber latex warning label.

A customer notification email dated 11/30/2021 was sent with recall instructions as follows: 1. Check: Please review your inventory to determine if the manufacturer item numbers and lot numbers listed in the table are in your inventory. 2. Quarantine: If the affected kits are identified, please quarantine the product and do not further distribute. 3. Label Affected kits: Use the label template attached to this notice to label affected kits in your inventory prior to shipping to customers. The label includes the statement "This kit contains a URETHRAL CATHETER RED RUBBER 12FR that contains natural rubber latex which may cause allergic reactions." The label should be placed in a location on the outer wrapper of the kits that is visible to end users. 4. Reply: Please complete the attached reply form indicating any inventory on hand at your facility. If you do not have inventory, please return the form indicating "0" inventory on hand. 5. Notify: Please immediately notify any customers to who, you have distributed or forwarded kits affected by this medical device correction notice. You may include a copy of this notice and the attached label template with your customer notification. 6. End users: Notices sent to end users should include the label template and instruction to label affected kits in their inventory. The label should be placed in a location on the outer wrapper of the kits that is visible to users of the kits.