🔍 RecallPedia

a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira Pleural / Peritoneal Drainage Kit Aspira 1000 mL Sterile Model Number: 4992301.

Class I - Dangerous
🏥 Medical Devices Recalled: May 25, 2022 Mckesson Medical-Surgical Inc. Corporate Office Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    GTIN: a. 00884450394984 (EA); 00801741045011 (EA); 10801741045018 (CA); 10884450394981 (CA); 20801741045015 (BX); 20884450394988 (BX). b. 00801741045035 (EA); 00884450394861 (EA); 10801741045032 (CA); 10884450394868 (CA); 20801741045039 (BX); 20884450394865 (BX)
  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:
Mckesson Medical-Surgical Inc. Corporate Office
Reason for Recall:
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

a. MERIT MEDICAL SYSTEMS Aspira Dressing Kit Aspira Model Number: 4991503. b. MERIT MEDICAL SYSTEMS Aspira Pleural / Peritoneal Drainage Kit Aspira 1000 mL Sterile Model Number: 4992301.

Product Codes/Lot Numbers:

GTIN: a. 00884450394984 (EA); 00801741045011 (EA); 10801741045018 (CA); 10884450394981 (CA); 20801741045015 (BX); 20884450394988 (BX). b. 00801741045035 (EA); 00884450394861 (EA); 10801741045032 (CA); 10884450394868 (CA); 20801741045039 (BX); 20884450394865 (BX)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1599-2022

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