Device product
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.
Z-1787-2026
Product summary
- Event
- Event 98495
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 70 units
- Official record key
device-enforcement:Z-1787-2026
Official wording
Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Code information: 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 pattern: Worldwide distribution.
Derived failure modes
-
Unknown
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.