Clotting time cartridges recalled over dried blood on carton labels
Medtronic is recalling 3,850 HR-ACT clotting time cartridges after trace amounts of dry blood were observed on the external carton label and instructions in five boxes.
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: Scored 2 because the record describes trace contamination on outer packaging, with no stated effect on the cartridges or any reported harm.
Plain-English summary
Medtronic HR-ACT High Range Activated Clotting Time Cartridges, REF 402-03, are being recalled.
Medtronic personnel observed trace amounts of dry blood on the external carton label and the Instructions for Use in five boxes of one lot of ACT cartridges.
The recall covers 3,850 units carrying UDI/DI 20763000433844, from lot 232135734. The product was distributed in Hawaii and New York. The FDA has classified the action as Class II.
The enforcement record describes contamination on outer packaging rather than on the cartridges themselves, and states no health consequence or injuries. Laboratories holding the affected lot should follow Medtronic's instructions.
The recalled product
- Product
- Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 3,850
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 (2)
- UDI/DI 20763000433844
- Lot Number 232135734
Distribution
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