Recall Z-0053-2025 ยท FDE Laparoscopy Kit
MEDLINE INDUSTRIES, LP - Northfield
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
| Date | Oct 10, 2024 (initiated Aug 28, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | 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 |
| Quantity | 72 kits |
| Distribution | US Nationwide distribution in the state of CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.