Medline Open Heart Kits Recalled Due to Incorrect Cannula Labeling
Medline Industries is recalling 22 Open Heart NIMC Kits because they contain Medtronic DLP Vessel Cannulae that were incorrectly labeled during manufacturing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a labeling error without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medline Industries, LP is recalling 22 units of the MEDLINE OPEN HEART NIMC KIT (REF DYNJ908840). The recall is due to the kits containing Medtronic DLP Vessel Cannulae from specific lots where product for model 30001 was incorrectly labeled as model 30000 during manufacturing.
The affected kits were distributed nationwide in the United States. The specific lot number for the kits is 24BMF235. The recall is classified as Class II by the FDA.
Healthcare facilities and consumers should stop using the affected kits and contact Medline Industries for further instructions or a return.
The recalled product
- Product
- MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 22
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI 40195327185078 (case)
- 10195327185077 (each)
- Lot Numbers: 24BMF235
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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