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Moderate riskFDA DeviceClass II

Cook Medical arterial pressure monitoring trays recalled for incorrect expiration dates

Cook Medical arterial pressure monitoring trays in three specific lots were labeled with expiration dates that go beyond their actual shelf life. This means the devices may not perform as expected if used after their true expiration. Twenty units were affected and distributed worldwide.

From the FDA notice · Read the official notice ↗ · All Cook recalls

What to do

  1. Check your Cook Medical arterial pressure monitoring trays against the lot numbers listed
  2. Do not use units from lots 15894185X, 15747314X, or 15264260X
  3. Contact Cook Medical or your supplier for replacement or proper disposal
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 18 products — see all of them.

Details

Units affected
20 units
Illnesses reported
None reported
Manufactured in
750 N Daniels Way, Bloomington, IN, United States
Classification
Class II
Recall number
Z-1778-2026

In the FDA's words

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

18 products in this recall

Cook Medical procedure kits recalled for expiration date errors

Cook Medical is recalling 18 product listings, including catheter, tracheostomy, and central venous kits and trays, because some affected lots were labeled with expiration dates longer than their true shelf life. No injuries have been reported, and the products were distributed worldwide.

The agency lists each product separately. Check every one you might have.

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Related topics

Expiration date errorMedical devicesSold nationwideMore from FDA Device