Class II U.S. Food and Drug Administration

Cook Medical Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer recall: Products from the affected device lots were labeled with expiration dates

Recall published 6 months ago

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-1779-2026
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
916 units
Made in
United States
Lot / code info
Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270802(10)16189446, Lot Number 16189446; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270803(10)16189593, Lot Number 16189593; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270725(10)16175956, Lot Number 16175956; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270725(10)16175957, Lot Number 16175957; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270803(10)16189597, Lot Number 16189597; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)270725(10)16175953, Lot Number 16175953; Reference Part Number C-PTIS-100-HC-G-EU, UDI (01)00827002576858(17)271001(10)16460934, Lot Number 16460934; Reference Part Number C-PTIS-100-HC-G-NA, UDI (01)00827002576827(17)280318(10)16514949, Lot Number 16514949; Reference Part Number C-PTIS-100-HC-G-NA, UDI (01)00827002576827(17)270725(10)16175948, Lot Number 16175948; Reference Part Number C-PTIS-100-UNL-HC-G-EU, UDI (01)00827002576872(17)260101(10)15151627, Lot Number 15151627; Reference Part Number C-PTIS-100-UNL-HC-G-EU, UDI (01)00827002576872(17)270627(10)16131781, Lot Number 16131781; Reference Part Number C-PTIS-100-UNL-HC-G-EU, UDI (01)00827002576872(17)280218(10)16471138, Lot Number 16471138; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270725(10)16175951, Lot Number 16175951; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270725(10)16175949, Lot Number 16175949; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270724(10)16174015, Lot Number 16174015; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270725(10)16175955, Lot Number 16175955; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270724(10)16174023, Lot Number 16174023; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)270801(10)16187746, Lot Number 16187746; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)260327(10)15548776, Lot Number 15548776; Reference Part Number C-PTIS-100-UNS-HC-G-EU, UDI (01)00827002576865(17)280121(10)16429827, Lot Number 16429827.
UPC codes
00827002576858, 00827002576827, 00827002576872, 00827002576865

Products covered by this recall

COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G57682; Reference Part Number C-PTIS-100-UNL-HC-G-EU, Order Number G57687; Reference Part Number C-PTIS-100-UNS-HC-G-EU, Order Number G57686.

Check your product

The notice names 25 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.

  • 00827002576858
  • 00827002576827
  • 00827002576872
  • 00827002576865

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 16189446
  • 16189593
  • 16175956
  • 16175957
  • 16189597
  • 16175953
  • 16460934
  • 16514949
  • 16175948
  • 15151627
  • 16131781
  • 16471138
  • 16175951
  • 16175949
  • 16174015
  • 16175955
  • 16174023
  • 16187746
  • 15548776
  • 16429827. — 916 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.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

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 00827002576858, 00827002576827, 00827002576872; lot code 16189446, 16189593, 16175956; 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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