Recall Weekly
Moderate riskFDA DeviceClass II

Cook Medical Blue Rhino G2 tracheostomy introducer tray recalled for incorrect expiration dates

Cook Medical's Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray was labeled with expiration dates that are longer than the actual shelf life of the product. This affects specific lot numbers distributed worldwide. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Cook recalls

What to do

  1. Check your inventory for the affected lot numbers listed in this recall
  2. Do not use products beyond their true shelf life, even if the package label shows a later date
  3. Contact Cook Medical or your supplier for instructions on replacement or return
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 18 products — see all of them.

Details

Units affected
441 units
Illnesses reported
None reported
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Classification
Class II
Recall number
Z-1780-2026

In the FDA's words

Description
COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Number G57706; Reference Part Number C-PTISY-100-UNS-HC-G-NA, Order Number G57704. Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)270730(10)16183353X, Lot Number 16183353X; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)270524(10)16076948, Lot Number 16076948; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)260222(10)15473203X, Lot Number 15473203X; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)260201(10)15476984X, Lot Number 15476984X; Reference Part Number C-PTISY-100-HC-G-NA, UDI (01)00827002577039(17)261020(10)15719188X, Lot Number 15719188X; Reference Part Number C-PTISY-100-UNL-HC-G-NA, UDI (01)00827002577060(17)270814(10)16205108, Lot Number 16205108; Reference Part Number C-PTISY-100-UNS-HC-G-NA, UDI (01)00827002577046(17)270528(10)16080161X, Lot Number 16080161X; Reference Part Number C-PTISY-100-UNS-HC-G-NA, UDI (01)00827002577046(17)270901(10)16435112, Lot Number 16435112. Distribution: Worldwide distribution. Affected quantity: 441 units
Hazard
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

18 products in this recall

Cook Medical procedure kits recalled for expiration date errors

Cook Medical is recalling 18 product listings, including catheter, tracheostomy, and central venous kits and trays, because some affected lots were labeled with expiration dates longer than their true shelf life. No injuries have been reported, and the products were distributed worldwide.

The agency lists each product separately. Check every one you might have.

More from Cook

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Related topics

Expiration date errorMedical devicesSold nationwideMore from FDA Device