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.
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Cook Incorporated
- 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
- Reason / hazard
- Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution.
- Recall initiated
- 2026-03-05
- Code info
- 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;
- Product quantity
- 20 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Bloomington
- State
- IN
- Country
- United States
- Event id
- 98495
Free daily digest + "My products" watchlist