Cook Inc. Recalls Femoral Artery Pressure Monitoring Sets for Labeling Error
Cook Inc. is recalling 266 femoral artery pressure monitoring sets because the labels fail 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 a heparin coating. As no illnesses or injuries are reported in the source text, this fits the criteria for a moderate severity labeling issue.
Plain-English summary
Cook Inc. is voluntarily recalling 266 units of the Femoral Artery Pressure Monitoring Set (Catalog # C-PMS-300-CHILDRENS-A- 032988, all lots). The recall was initiated because the product labels do not state that the device is heparin-coated.
The affected products were distributed nationally. This labeling omission may prevent healthcare providers from being aware of the heparin coating, which could impact clinical decision-making regarding anticoagulation management.
Healthcare facilities and consumers should stop using the affected products and contact Cook Inc. for further instructions or a return.
The recalled product
- Product
- Femoral Artery Pressure Monitoring Set
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 266
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-PMS-300-CHILDRENS-A- 032988 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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