FDA-Device2026-04-15Class II
COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.
Cook Incorporated
Hazard
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Sold states
Worldwide distribution.
Affected count
70 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1787-2026Original summary
COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251. Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Reference Part Number C-NTSE-2.4-115-NC3, UDI (01)00827002362505(17)261103(10)15741134, Lot Number 15741134; Reference Part Number C-NTSE-2.4-115-NCT4, UDI (01)00827002362512(17)270118(10)15855141, Lot Number 15855141. Distribution: Worldwide distribution. Affected quantity: 70 units
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