COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Re…
Cook Incorporated · Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Open FDA's page for this record- Cfres ID
- 218921
- Product res number
- Z-1781-2026
- Event date initiated
- 2026-03-05
- Event date posted
- 2026-04-06
- Recall status
- Open, Classified
- Res event number
- 98495
- Product code
- JOH
- Firm FEI number
- 1820334
- Recalling firm
- Cook Incorporated
- Address 1
- 750 N Daniels Way
- City
- Bloomington
- State
- IN
- Postal code
- 47404-9120
- Additional info contact
- Cook Medical Customer Relations Department 812-457-4500
- Reason for recall
- Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Root cause description
- Incorrect or no expiration date
- Product quantity
- 484 units
- Distribution pattern
- Worldwide distribution.
- Product description
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.
- Code info
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.
- 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 (FieldActionsNA@CookMedical.com). 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: CustomerRelationsNA@CookMedical.com. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
- K numbers
- K133597
- Harmonized identifiers (openFDA)
- Device name
- Tube Tracheostomy And Tube Cuff
- Medical specialty description
- Anesthesiology
- Regulation number
- 868.5800
- Device class
- 2
- K number
- K040014, K172720, K100995, K954749, K914183, K123699, K944178, K914088, K973829, K897102, K897059, K924660, K022212, K923156, K133597, K051416, K945513, K122531, K011210, K990905, K150844, K936133, K182861, K954661, K921733, K890194, K922665, K936224, K081440, K000964, K897005, K932016, K910362, K142298, K903699, K043160, K193133, K894614, K894050, K982128 +69 more
- Registration number
- 2032112, 2024841, 8032044, 1058584, 3008278458, 3012542015, 3031233007, 1314417, 3018094310, 3030447506, 3030733800, 2011171, 8040412, 1928237, 3008132398, 3014461810, 3017210488, 3010041511, 3012502601, 3030626857, 3016678045, 3030446844, 2025816, 8010485, 8010939, 3011987967, 2219920, 3014054118, 3007502289, 3005941719, 2648727, 3004365956, 3002807561, 8020889, 3012421607, 3014579161, 3037918935, 1319639, 2936999, 8030673 +32 more
- FEI number
- 2024841, 3008278458, 3031233007, 3030733800, 3012542015, 1928237, 1314417, 3018094310, 3030447506, 2011171, 2025816, 3017210488, 3014461810, 3010041511, 3005747797, 3012502601, 3016678045, 3030626857, 3030446844, 3011987967, 2219920, 3014054118, 3002806269, 3007502289, 3004213967, 2648727, 3004365956, 3002807561, 3002808440, 3012421607, 3014579161, 3002558692, 3037918935, 3002807111, 3003076831, 2936999, 1721686, 3014479313, 1219795, 3021632375 +32 more