Cook Medical micro wire guides labeled with overstated expiration dates
Cook Medical is recalling Approach CTO-12 Micro Wire Guides because affected lots were labeled with expiration dates that exceed the product's true shelf life. 49 units are affected.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where an overstated expiry date can lead to use of a sterile device beyond its validated shelf life, a risk of harm with no injuries reported.
Plain-English summary
Cook Medical is recalling the Approach CTO-12 Micro Wire Guide, reference part numbers CMW-14-190-12G (order number G50787) and CMW-14-300-12G (order number G50791). The action covers 49 units.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life of the product. A wire guide carrying an overstated expiry can be held and used after the point at which its sterility and performance were validated. The FDA classified the action as Class II.
Distribution was worldwide. The wire guides are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the reference part numbers, UDIs and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Cook Medical.
The recalled product
- Product
- COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791
- Manufacturer
- Cook Incorporated
- Category
- Medical Device — Wire guide
- Affected units
- 49
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 (8)
- Reference Part Number CMW-14-190-12G
- UDI (01)00827002507876(17)260509(10)15885574X
- Lot Number 15885574X
- UDI (01)00827002507876(17)281203(10)15783003X
- Lot Number 15783003X
- Reference Part Number CMW-14-300-12G
- UDI (01)00827002507913(17)260227(10)15416547
- Lot Number 15416547.
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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