Medline Heart Overhead Table Pack recalled for incorrect model labeling
Medline Industries recalls Heart Overhead Table Packs due to incorrect labeling. Some kits were marked as model 30000 when they should be model 30001.
What this means for you
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 on medical device kits. No deaths, serious injuries, or illnesses are reported. The hazard is incorrect model identification due to manufacturing labeling error, which presents a theoretical risk but no actual harm has been documented.
Plain-English summary
Medline Industries, LP is recalling Heart Overhead Table Packs (Reference DYNJ0778508J) due to incorrect product labeling. During manufacturing, certain kits containing DLP Vessel Cannulae were labeled as model 30000 when they should have been labeled as model 30001.
The recall affects 60 kits distributed nationwide throughout the United States. The affected products are identified by lot numbers 24BMD381 and 24BMJ452.
Healthcare facilities that received affected kits should verify the actual product model and ensure proper identification. Affected units should be handled according to manufacturer instructions.
The recalled product
- Product
- MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Hazard
- mislabeling
- incorrect-model
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 (4)
- UDI/DI 40195327563784 (case)
- 10195327563783 (each)
- Lot Numbers: 24BMD381
- 24BMJ452
Distribution
Distributed nationwide across the United States.
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