Medline convenience kits containing semi-rigid suction liners labeled… — Class II medical device recall Z-3107-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-09-18, distributed nationwide. Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500
| Recall number | Z-3107-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2024-06-27 |
| Classified | 2024-09-11 |
| Reported by FDA | 2024-09-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, PA |
| Quantity | 1,646 units |
| UPC / GTIN / UDI-DI | 10193489951363, 10195327023034, 10195327200572, 10195327258511, 10195327332402, 10195327507060, 40193489951364, 40195327023035, 40195327200573, 40195327258512, 40195327332403, 40195327507061 |
| Lot numbers | 23LMC958, 23LMG790, 24ABB080, 24ABX948, 24AME311, 24BBS291, 24BMG878, 24BMI437, 24CLA959, 24DMA783, 24FBC609 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3107-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.