medical MODERATE Updated 2026-04-15

Cook Incorporated recalls COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy In

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Recalled 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.

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Hazard / Issue

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Issued by

FDA

Distribution: Worldwide distribution.
Lot/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.

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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View official government recall

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