Cook Inc. Recalls Left Atrial Catheter Sets Due to Labeling Error
Cook Inc. is recalling 56 Left Atrial Catheter Sets because the labels failed to state that the product is heparin-coated.
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 hazard is a minor labeling error regarding heparin coating, which fits the criteria for moderate severity involving labeling issues.
Plain-English summary
Cook Inc. is recalling 56 units of the Left Atrial Catheter Set, Catalog # C-ULAP-5.0-60-DTK-BH, all lots. The recall was initiated because the product labels do not state that the product is heparin-coated.
The affected products were distributed nationally. The source text does not specify the number of reported illnesses or injuries associated with this recall.
Healthcare providers and consumers should stop using the affected Left Atrial Catheter Sets and contact Cook Inc. for further instructions or a replacement.
The recalled product
- Product
- Left Atrial Catheter Set
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Catheter
- 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 (1)
- Catalog # C-ULAP-5.0-60-DTK-BH ALL LOTS
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 20 recalled by Cook Inc. 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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