FDA-Device2026-04-15Class II

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419

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 Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1778-2026

Original summary

COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419 Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Reference Part Number APMY-2.5-15-0-2.5, UDI (01)00827002584129(17)270212(10)15894185X, Lot Number 15894185X; Reference Part Number APMY-2.5-15-0-2.5, UDI (01)00827002584129(17)261108(10)15747314X, Lot Number 15747314X; Reference Part Number APMY-4.0-21J-1-12, UDI (01)00827002584198(17)260202(10)15264260X, Lot Number 15264260X; Distribution: Worldwide distribution. Affected quantity: 20 units

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