FDA Device recall Z-3112-2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D
- FDA Device
- Class II
- ongoing
- Published 2024-09-18
On 2024-09-18 the FDA classified a Class II recall of Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D by Medline Industries Northfield, citing 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 pot….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3112-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-27 |
| Published | 2024-09-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO KIT, Pack Number DYKE1350D; b) ENDO KIT, Pack Number DYKE1514B
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.
Identifiers
| code_info | a) DYKE1350D: UDI/DI case 40193489339797, UDI.DI each 10193489339796; Lot Numbers: 24CBG448, 24EBF166; b) DYKE1514B:…a) DYKE1350D: UDI/DI case 40193489339797, UDI.DI each 10193489339796; Lot Numbers: 24CBG448, 24EBF166; b) DYKE1514B: UDI/DI case 40193489797832, UDI.DI each 10193489797831; Lot Numbers: 24CBR722, 24FBA408 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3112-2024%22
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