Cricothyrotomy catheter sets labeled with overstated expiration dates
Cook Incorporated is recalling Melker Universal Cuffed Emergency Cricothyrotomy Catheter Sets because affected lots were labeled with expiration dates that exceed the true 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 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 emergency airway device beyond its validated shelf life, a risk of harm with no injuries reported.
Plain-English summary
Cook Incorporated is recalling the Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set, reference part numbers C-TCCSB-500-UNI (order number G32193) and C-TCCSB-500-UNI-01 (order number G47665). The action covers 476 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 for emergency airway access 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 the manufacturer.
The recalled product
- Product
- Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.
- Manufacturer
- Cook Incorporated
- Affected units
- 476
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 (20)
- Reference Part Number C-TCCSB-500-UNI
- UDI (01)00827002321939(17)270803(10)NS16189671
- Lot Number NS16189671
- Reference Part Number C-TCCSB-500-UNI-01
- UDI (01)00827002476653(17)270805(10)16191668
- Lot Number 16191668
- UDI (01)00827002476653(17)270807(10)16195472
- Lot Number 16195472
- UDI (01)00827002476653(17)270807(10)16195467
- Lot Number 16195467
- UDI (01)00827002476653(17)270805(10)16191666
- Lot Number 16191666
- UDI (01)00827002476653(17)270805(10)16191677
- Lot Number 16191677
- UDI (01)00827002476653(17)270805(10)16191661
- Lot Number 16191661
- UDI (01)00827002476653(17)270812(10)16200360
- Lot Number 16200360
- UDI (01)00827002476653(17)270731(10)16185929
- Lot Number 16185929
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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