FDAHealthMarch 5, 2026
Cook Incorporated — 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.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- March 5, 2026
Worldwide distribution.
What's affected?
- 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
- Brand
- Cook Incorporated
- Lot code
- 15894185X
Additional details
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;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 20 units.
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