FDA DeviceClass IINotable

FDA Recall: Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Numbe

Date: 2026-03-18
Brand: Medline Industries, LP
Category: Medical Device
FDA Class: Class II

Description

The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.

Hazard

The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.

Remedy

2894 units

View original recall →
Share:

Related Recalls

2026-05-06 · FDA_DEVICE
FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges (4077 in total), LAMINECTOMY, CRANI
Medline Industries, LP
2026-05-06 · FDA_DEVICE
FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. SPINE PROCE
Medline Industries, LP
2026-05-06 · FDA_DEVICE
FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. PLASTICS
Medline Industries, LP
2026-05-06 · FDA_DEVICE
FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: ANGIO PACK-LF,
Medline Industries, LP