Cook Medical Micro Wire Guides Recalled Due to Incorrect Expiration Dates
Cook Incorporated is recalling specific lots of COOK MEDICAL Approach CTO-6 Micro Wire Guides because they were labeled with expiration dates that exceed their actual shelf life.
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 expiration dates, which falls under the rubric for low-risk contamination or minor labeling errors.
Plain-English summary
Cook Incorporated is recalling COOK MEDICAL Approach CTO-6 Micro Wire Guides (Reference Part Number CMW-14-190-6G, Order Number G50786). The affected products were labeled with expiration dates that exceed the true shelf life of the device.
This recall affects 15 units with Lot Number 15288005. The distribution of these products was worldwide.
Users should check their inventory for the affected lot number and contact the manufacturer for further guidance.
The recalled product
- Product
- COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
- Manufacturer
- Cook Incorporated
- Hazard
- Affected units
- 15
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 (01)00827002507869(17)270708(10)15288005
- Lot Number 15288005
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 18 recalled by Cook Incorporated 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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