Cook Incorporated recalls COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part
- Recalling company
- Cook Incorporated
- Product
- 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.
- Reason
- Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 5, 2026
- Reported
- Apr 15, 2026
- Distribution
- Worldwide distribution.
- Status
- Ongoing
- Quantity
- 916 units
- Lot / codes
- 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)
- Company location
- Bloomington, IN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1779-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1779-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.