Recall Z-0771-2023

Reason for recall

The stylet is longer than specified on the label

FDA-determined cause: Under Investigation by firm

Action taken

The firm issued an URGENT: RECALL NOTIFICATION LETTER to its consignees on 12/02/2022 by email. The notice requested the following: "Actions to be Taken: The following steps are to be taken by all impacted customers: 1. Please be aware that this issue may be present in your company s inventory (refer to the impacted lot number listed below). Please communicate the possibility of this issue to all parties in your facility who may be impacted so that they are aware of the potential risks associated with this product and so replacement products may be obtained, if necessary. 2. Complete the enclosed Notice Reply Form and fax it to the attention of RMI s QA Recall Coordinator, at 770-888-8524 or scan the completed form and e-mail to quality@remmed.com. The form lists the catalog number(s) and lot number(s) of impacted product our records indicate your facility has received. 3. Enter the quantity of the affected product you wish to be replaced in the Quantity to be Replaced column. Enter a 0 if you do not require any replacements for this lot. 4. Dispose of any affected inventory per your facility s policies and procedures." "NOTE: If you are a distributor who has physically shipped this product to another location, such as a customer or end user, please provide this letter to the recipient of the product so that the requested actions above may be completed."