Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU

Class I - Dangerous

🏥 Medical Devices Recalled: September 18, 2023 Atrium Medical Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
UDI-DI: (1)4000-100N DRAIN, EXPRESS, SINGLE 20650862115134; (2) 4050-100N DRAIN, EXPRESS, BRU 20650862115141 All lots within labeled product expiry Manufacturing Dates: Any product manufactured on and after July 21, 2020 Distribution Dates: Any product shipped on and after August 6, 2020
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Atrium Medical Corporation
Reason for Recall:: Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU

Product Codes/Lot Numbers:

UDI-DI: (1)4000-100N DRAIN, EXPRESS, SINGLE 20650862115134; (2) 4050-100N DRAIN, EXPRESS, BRU 20650862115141 All lots within labeled product expiry Manufacturing Dates: Any product manufactured on and after July 21, 2020 Distribution Dates: Any product shipped on and after August 6, 2020