Device product
Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ GYN LAPAROSCOPY, Pack Number DYNJ909739
Z-3118-2024
Product summary
- Event
- Event 95128
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 55 units
- Official record key
device-enforcement:Z-3118-2024
Official wording
Reason: Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Code information: DYNJ909739: UDI/DI case 40195327464692, UDI/DI each 10195327464691, Lot Numbers: 24BBL055, 24CBR861
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Derived failure modes
-
Unknown
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.