High FDA (Devices)·Z-1781-2026·Announced 2026-04-15

Cook Medical tracheostomy introducer sets labeled with overstated expiration dates

Cook Medical is recalling Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Sets because affected lots were labeled with expiration dates that exceed the true shelf life. 484 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 Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set, reference part numbers C-PTIS-100-FLEX-HC (order number G32092) and C-PTIS-100-HC (order number G12115). The action covers 484 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 numbers and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Cook Medical.

The recalled product

Product: 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.
Manufacturer: Cook Incorporated
Category: Medical Device — Tracheostomy set
Hazard: expiration-date-error
shelf-life
sterility-risk
class-ii
mislabeling
Affected units: 484

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-PTIS-100-FLEX-HC
UDI (01)00827002320925(17)270812(10)NS16200246
Lot Number NS16200246
UDI (01)00827002320925(17)270803(10)NS16189601
Lot Number NS16189601
UDI (01)00827002320925(17)270827(10)NS16226797
Lot Number NS16226797
UDI (01)00827002320925(17)270812(10)NS16200247
Lot Number NS16200247
UDI (01)00827002320925(17)270803(10)NS16189598
Lot Number NS16189598
UDI (01)00827002320925(17)270803(10)NS16189586
Lot Number NS16189586
UDI (01)00827002320925(17)270803(10)NS16189600
Lot Number NS16189600
UDI (01)00827002320925(17)270620(10)16120672
Lot Number 16120672
UDI (01)00827002320925(17)270803(10)NS16189607
Lot Number NS16189607
Reference Part Number C-PTIS-100-HC

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.

See all 18 products in this recall →

Same manufacturer · Cook Incorporated

See all →

Critical
Aurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
FDA (Devices) · 2026-05-13
Critical
Cook Centimeter Sizing Catheter recall due to marker band cracking
FDA (Devices) · 2026-05-13
Severe
Beacon Tip Centimeter Sizing Catheter recalled for cracking marker bands
FDA (Devices) · 2026-05-13
High
Cook Medical extubation set labeled with an overstated expiration date
FDA (Devices) · 2026-04-15
High
Cook Medical Spectrum central venous catheter trays carry overstated expiration dates
FDA (Devices) · 2026-04-15

Same hazard · expiration date error