CLASS II ONGOING Device recall · Reported 18 Sep 2024 · FDA Enforcement Report
Medline convenience kits containing semi-rigid suction recalled
Medline Industries LP - Northfield is recalling Medline convenience kits containing semi-rigid suction liners labeled as follows: a) OPEN, distributed nationwide in the US. The recall was initiated on 27 Jun 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3107-2024
- FDA event ID
- 95128
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Jun 2024
- FDA classified
- 11 Sep 2024
- Reported
- 18 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 27 Jun 2024 | Recall initiated by company | |
| 11 Sep 2024 | Classified by FDA | +76 days |
| 18 Sep 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
16 other products · FDA event 95128This product is part of a recall event; the main page for the event is Medline convenience kits containing semi-rigid suction recalled.
More recalls from Medline Industries LP - Northfield
All 792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
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Other Heart & Vascular Devices recalls
All 6,268| Reported | Class | Recall | Company | Reason | Where |
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| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Fathom/027/Straight/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/155 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |
| Device | CLASS II | Direxion Torqueable Microcatheter, Ngmc/Single/021/J/1RO/130 recalled | Boston Scientific Cork | Device Malfunction | Nationwide |