Z-1779-2026Class II
COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number...
Cook Incorporated / initiated 2026-03-05 / Open, Classified / root cause: labeling and UDI
Cook Incorporated began a recall of 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... on . FDA classified it as Class II and gives the reason as "Products from the affected device lots were labeled with expiration dates that exceed the true shelf life". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-1779-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- 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.
- Product code
- JOH Tube Tracheostomy And Tube Cuff
- Reason for recall
- Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Root cause tag
- labeling and UDI
- FDA root cause
- Incorrect or no expiration date
- Action
- Cook Medical issued an URGENT: MEDICAL DEVICE RECALL to its consignee on 3/5 2026 via courier or email. The notice explained the issue, potential risk to health, and requested the following: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email ([email protected]). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: [email protected]. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
- Quantity in commerce
- 916 units
- Distribution
- Worldwide distribution.
- Product codes and lots
- 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.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1775-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1776-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1777-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1778-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1779-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1780-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1781-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1782-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1783-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1784-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1785-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1786-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1787-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1788-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1789-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1790-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1791-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1792-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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