FDA-Device2026-04-15Class II
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
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
20 units
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Products
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1786-2026Original summary
COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775 Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, UDI (01)00827002297753(17)261005(10)NS15690755, Lot Number NS15690755; Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, UDI (01)00827002297753(17)260426(10)NS15408335, Lot Number NS15408335. Distribution: Worldwide distribution. Affected quantity: 20 units
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