Medical Device Kit Incorrectly Labeled With Wrong Model Number
Medline Industries recalls MEDLINE KIT CV I II vessel cannulae kits because product for model 30001 was incorrectly labeled as model 30000 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: This is an FDA Class II recall involving a labeling error with no reported injuries or illnesses. The rubric identifies minor labeling errors as Moderate severity.
Plain-English summary
Medline Industries, LP is recalling certain MEDLINE KIT CV I II, Reference DYNJ906071B, which are medical device kits containing DLP Vessel Cannulae. These kits have been distributed nationwide in the United States.
During manufacturing, certain vessel cannulae kits intended for model 30001 were incorrectly labeled as model 30000. Lot number 24ABA223 is affected, with 56 kits involved in this recall. Medline Industries identified the labeling error.
The recalled product
- Product
- MEDLINE KIT CV I II, REF DYNJ906071B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Hazard
- Affected units
- 56
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 40195327227235 (case)
- 10195327227234 (each)
- Lot Numbers: 24ABA223
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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