Recall Z-1435-2023

Reason for recall

The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.

FDA-determined cause: Nonconforming Material/Component

Action taken

The recalling firm issued letters dated 3/22/2023 via email the same day. The letter explained the issue, identified the affected product, and listed the actions to be taken by the customer. The actions included checking their inventory for the affected product, segregate and quarantine all affected kits in their inventory, and use the attached label template to print warning labels to be affixed to all affected kits in their inventory. The label should be applied to each affected kit and outer product case in a prominent location to end users of the kits. The location chosen should not cover critical product information found on the existing label. The label instructs users to remove and discard the STERIS Light Handle Cover(s) when the kit is opened for use and to pull a sterile replacement from stock. A reply form is included with the letter for completion to indicate the consignee's actions in response to the notice. The response form is to be returned to the recalling firm via email. If the direct account consignee further distributed or forwarded the affected product, they are to immediately notify those customers. A copy of the ROi CPS recall letter, the letter from STERIS, and the attached label template may be included.