Cook Inc. Recalls Central Venous Catheter Trays Due to Labeling Error
Cook Inc. is recalling 13 Central Venous Catheter Trays because the label fails 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 involves a labeling error regarding heparin coating, which fits the rubric for minor labeling errors or low-risk issues without reported injuries.
Plain-English summary
Cook Inc. is recalling 13 units of the Central Venous Catheter Tray, Catalog # TSCFNB-35-180-SPENCERMOD-BH, across all lots. The recall was initiated because the product label does not state that the device is heparin-coated.
The affected products were distributed nationally. The U.S. Food and Drug Administration has classified this as a Class II recall. No specific dates of distribution or additional details regarding the distribution scope are provided in the source text.
Healthcare facilities and consumers should stop using the affected Central Venous Catheter Trays and contact Cook Inc. for further instructions or a replacement.
The recalled product
- Product
- Central Venous Catheter Tray
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 13
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 # TSCFNB-35-180-SPENCERMOD- 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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