Cook Medical Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer recall: Products from the affected device lots were labeled with expiration dates
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
The hazard: Device safety concern
A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
What the notice says: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-1781-2026
- Published
- April 15, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Cook Incorporated
- Product type
- Medical devices
- Units affected
- 484 units
- Made in
- United States
- Lot / code info
- Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270812(10)NS16200246, Lot Number NS16200246; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189601, Lot Number NS16189601; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270827(10)NS16226797, Lot Number NS16226797; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270812(10)NS16200247, Lot Number NS16200247; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189598, Lot Number NS16189598; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189586, Lot Number NS16189586; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189600, Lot Number NS16189600; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270620(10)16120672, Lot Number 16120672; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189607, Lot Number NS16189607; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189604, Lot Number 16189604; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189588, Lot Number 16189588; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189603, Lot Number 16189603; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189608, Lot Number 16189608; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189589, Lot Number 16189589; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189602, Lot Number 16189602; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270620(10)16120666, Lot Number 16120666; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189594, Lot Number 16189594.
- UPC codes
- 00827002320925, 00827002121157
Products covered by this recall
COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.
Check your product
The notice names 20 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 00827002320925
- 00827002121157
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- NS16200246
- NS16189601
- NS16226797
- NS16200247
- NS16189598
- NS16189586
- NS16189600
- 16120672
- NS16189607
- 16189604
- 16189588
- 16189603
- 16189608
- 16189589
- 16189602
- 16120666
- 16189594. — 484 units
Model or item number
On the rating label, the box or the instruction sheet.
- UDI
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
Cook Incorporated — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
- Ask the supplier or clinic that provided it what the remedy is in your case.
- If you are a facility, quarantine affected stock and log the correction.
Claiming on a recalled device
Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.
- Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
- Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
- If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
- Log the date, the name and the reference number of every call. Device recalls can run for months.
Company contact: Cook Incorporated — 750 N Daniels Way, Bloomington, IN, 47404-9120
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Cook Incorporated medical devices recalled?
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 00827002320925, 00827002121157; lot code NS16200246, NS16189601, NS16226797; model number UDI. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
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