Medline Laparoscopy Pack (MEDLINE) – Endo Pocket Concern (2024)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the collection and extraction of tissues, organs, and calculi during general and laparoscopic procedures. The tube inside the pouch, which detaches during the removal process, may stretch out from the pouch opening if it is not precisely fixed during the production process. Medline has identified that this product is utilized as a component within the Medline-branded convenience kits.

Recommended Action

Per FDA guidance

The recalling firm issued letters on and dated 8/28/2024 via first class mail and email. The letter explained the reason for recall and instructed the customer that nothing was to be returned to Medline. The customer is to request a sticker to be placed on affected kits instructing the user to remove the recalled component. The consignee is required to immediately check their stock for the affected item number and affected lot numbers which can be located within the recall portal and quarantine all affected product immediately. The consignee is to use the link and information in the letter to complete their response form. They are to list the quantity of affected product in inventory on the form and submit the form. Upon receipt of the submitted response form, the consignee will receive over-labels to place on affected inventory with instructions for the user to remove the affected component prior to using the kit. The labels will be provided via FedEx overnight. If the consignee is a distributor or has resold or transferred the product to another company or individual, the consignee is to notify their downstream customers of this communication.