Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number... recall (Cook Incorporated)
Medical deviceClass IIOngoing
Summary: Cook Incorporated is recalling 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.. Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
What is being recalled
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.
Why
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution.
How to tell if yours is affected
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; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195472, Lot Number 16195472; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195467, Lot Number 16195467; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191666, Lot Number 16191666; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191677, Lot Number 16191677; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191661, Lot Number 16191661; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270812(10)16200360, Lot Number 16200360; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270731(10)16185929, Lot Number 16185929; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270904(10)16237917, Lot Number 16237917; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191674, Lot Number 16191674; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191671, Lot Number 16191671; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270806(10)16193388, Lot Number 16193388; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270806(10)16193387, Lot Number 16193387; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191667, Lot Number 16191667; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195473, Lot Number 16195473; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191662, Lot Number 16191662; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191689, Lot Number 16191689; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195468, Lot Number 16195468; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270927(10)16271019, Lot Number 16271019.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1785-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 5, 2026 |
| Reported | April 15, 2026 |
| Company | Cook Incorporated |
| Company location | Bloomington, IN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 476 units |
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