🔍 RecallPedia

Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

Class I - Dangerous
🏥 Medical Devices Recalled: September 21, 2023 ROi CPS Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
ROi CPS LLC
Reason for Recall:
Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the 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:

Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

Product Codes/Lot Numbers:

a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442

Distribution:

Distributed in: MO

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0315-2024

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