FDA Medical Device Recalls (openFDA)
Cook Incorporated: 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.
- Recall number
- Z-1785-2026
- Recalling firm
- Cook Incorporated
- 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.
- Status
- Open, Classified
- Initiated
- 2026-03-05
- Posted
- 2026-04-06
- Terminated
- not on file
- Reason
- Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Root cause
- Incorrect or no expiration date
- Action
- Cook Medical issued an URGENT: MEDICAL DEVICE RECALL to its consignee on 3/5 2026 via courier or email. The notice explained the issue, potential risk to health, and requested the following: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
- Quantity
- 476 units
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K160200","K010016"]
- PMA numbers
- not on file
- Product code
- BWC
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28