COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Or
Summary
The FDA issued a Class II for COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Refe by Cook Incorporated. Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life..
Details
Source
Device Recall
External ID
Z-1779-2026
Action Date
2026-04-15
Status
Ongoing
Category
device
Product Description
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.
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.
Quantity Affected: 916 units
Reason for Recall
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-05
Company
Bloomington, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 232 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Cook Incorporated has 88 FDA actions in our database, including 85 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cook Incorporated) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cook Incorporated have FDA actions?
Cook Incorporated has 88 FDA actions in our database, including 85 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1779-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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