FDA-Device2024-10-16Class II
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
MEDLINE INDUSTRIES, LP - Northfield
Hazard
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.
Sold states
US Nationwide distribution in the state of CA.
Affected count
72 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0053-2025Don't want to check this manually?
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