FDA Device recall Z-3107-2024
Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I
- 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) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I 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-3107-2024 |
| 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) OPEN HEART KIT,ALTA BATES HOSP, Pack Number DYK1002174I; b) ENDO KIT, Pack Number DYKE1558B; c) ENDO KIT, Pack Number DYKE1804A; d) VASCULAR-LF, Pack Number DYNJ900714C; e) MAJOR CARDIOVASC ADULT, Pack Number DYNJ905472B; f) AV FISTULA, Pack Number DYNJ908096A
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) DYK1002174I: UDI/DI case 40195327332403, UDI/DI each 10195327332402; Lot Numbers: 24CLA959; b) DYKE1558B: UDI/DI…a) DYK1002174I: UDI/DI case 40195327332403, UDI/DI each 10195327332402; Lot Numbers: 24CLA959; b) DYKE1558B: UDI/DI case 40195327258512, UDI/DI each 10195327258511; Lot Numbers: 24DMA783, 24BMG878, 23LMG790; c) DYKE1804A: UDI/DI case 40195327023035, UDI/DI each 10195327023034; Lot Numbers: 24BMI437, 24AME311, 23LMC958; d) DYNJ900714C: UDI/DI case 40193489951364, UDI/DI each 10193489951363; Lot Numbers: 24FBC609; e) DYNJ905472B: UDI/DI case 40195327200573, UDI/DI each 10195327200572; Lot Numbers: 24BBS291; f) DYNJ908096A: UDI/DI case 40195327507061, UDI/DI each 10195327507060; Lot Numbers: 24ABX948, 24ABB080 |
|---|
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-3107-2024%22
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