Z-1781-2026Class II
COOK MEDICAL Ciaglia Blue Rhino 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 Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; 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-1781-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Cook Incorporated
- Product
- COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.
- 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
- 484 units
- Distribution
- Worldwide distribution.
- Product codes and lots
- Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270812(10)NS16200246, Lot Number NS16200246; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189601, Lot Number NS16189601; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270827(10)NS16226797, Lot Number NS16226797; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270812(10)NS16200247, Lot Number NS16200247; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189598, Lot Number NS16189598; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189586, Lot Number NS16189586; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189600, Lot Number NS16189600; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270620(10)16120672, Lot Number 16120672; Reference Part Number C-PTIS-100-FLEX-HC, UDI (01)00827002320925(17)270803(10)NS16189607, Lot Number NS16189607; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189604, Lot Number 16189604; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189588, Lot Number 16189588; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189603, Lot Number 16189603; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189608, Lot Number 16189608; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189589, Lot Number 16189589; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189602, Lot Number 16189602; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270620(10)16120666, Lot Number 16120666; Reference Part Number C-PTIS-100-HC, UDI (01)00827002121157(17)270803(10)16189594, Lot Number 16189594.
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 |
FIRST ARTICLE / WEEKLY
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