Device product

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

Z-1778-2026

March 05, 2026

Class II

Product summary

Firm: Cook Incorporated
Event: Event 98495
Status: Ongoing
Classification: Class II
Quantity: 20 units
Official record key: device-enforcement:Z-1778-2026

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 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 pattern: Worldwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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