Cook Medical extubation set labeled with an overstated expiration date
Cook Medical is recalling Staged Extubation Sets because affected lots were labeled with expiration dates that exceed the product's true shelf life. 95 units are affected.
What this means for you
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 Cook Staged Extubation Set, reference part number C-CAE-14.0-83-EXTU, order number G24073, lot number 16010654. The action covers 95 units.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life of the product. A set 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 sets are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the reference part number, UDI and lot number in the recall notice, quarantine it, and follow the instructions issued by Cook Medical.
The recalled product
- Product
- COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
- Manufacturer
- Cook Incorporated
- Affected units
- 95
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 (3)
- Reference Part Number C-CAE-14.0-83-EXTU
- UDI (01)00827002240735(17)270509(10)16010654
- Lot Number 16010654.
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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