Z-1778-2026 Class II Ongoing
FDA device recall Z-1778-2026 was initiated by Cook Incorporated on March 5, 2026 and is designated Class II. Reason for recall: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. The recall status is ongoing. Affected quantity: 20 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2026
- Initiation Date
- March 5, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
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
Reason for Recall
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Distribution Pattern
Worldwide distribution.
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;