Reported Apr 15, 2026 · Ongoing
COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC,…
Cook Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
- COOK MEDICAL Ciaglia Blue Rhino Percutaneous
- Tracheostomy Introducer Set
Reference Part Number C-PTIS-100-FLEX-HCOrder Number G32092Reference Part Number C-PTIS-100-HCOrder Number G12115
- Lot codes and dates
17 of 17 products
Products covered by this recall Model / number Barcodes Product as published C-PTIS-100-FLEX-HC00827002320925Reference , UDI (01)00827002320925(17)270812(10)NS16200246, Lot Number NS16200246 C-PTIS-100-FLEX-HC00827002320925Reference , UDI (01)00827002320925(17)270803(10)NS16189601, Lot Number NS16189601 C-PTIS-100-FLEX-HC00827002320925Reference , UDI (01)00827002320925(17)270827(10)NS16226797, Lot Number NS16226797 C-PTIS-100-FLEX-HC00827002320925Reference , UDI (01)00827002320925(17)270812(10)NS16200247, Lot Number NS16200247 C-PTIS-100-FLEX-HC00827002320925Reference , UDI (01)00827002320925(17)270803(10)NS16189598, Lot Number NS16189598 C-PTIS-100-FLEX-HC00827002320925Reference , UDI (01)00827002320925(17)270803(10)NS16189586, Lot Number NS16189586 C-PTIS-100-FLEX-HC00827002320925Reference , UDI (01)00827002320925(17)270803(10)NS16189600, Lot Number NS16189600 C-PTIS-100-FLEX-HC00827002320925Reference , UDI (01)00827002320925(17)270620(10)16120672, Lot Number 16120672 C-PTIS-100-FLEX-HC00827002320925Reference , UDI (01)00827002320925(17)270803(10)NS16189607, Lot Number NS16189607 C-PTIS-100-HC00827002121157Reference , UDI (01)00827002121157(17)270803(10)16189604, Lot Number 16189604 C-PTIS-100-HC00827002121157Reference , UDI (01)00827002121157(17)270803(10)16189588, Lot Number 16189588 C-PTIS-100-HC00827002121157Reference , UDI (01)00827002121157(17)270803(10)16189603, Lot Number 16189603 C-PTIS-100-HC00827002121157Reference , UDI (01)00827002121157(17)270803(10)16189608, Lot Number 16189608 C-PTIS-100-HC00827002121157Reference , UDI (01)00827002121157(17)270803(10)16189589, Lot Number 16189589 C-PTIS-100-HC00827002121157Reference , UDI (01)00827002121157(17)270803(10)16189602, Lot Number 16189602 C-PTIS-100-HC00827002121157Reference , UDI (01)00827002121157(17)270620(10)16120666, Lot Number 16120666 C-PTIS-100-HC00827002121157Reference , UDI (01)00827002121157(17)270803(10)16189594, Lot Number 16189594. - Amount recalled
- 484 units
This recall covers 18 products
The agency filed one notice per product. You are reading one of them; the other 17 are below.
5 more are in the archive.
Why it was recalled
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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