🔍 RecallPedia

FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03

Class I - Dangerous
🏥 Medical Devices Recalled: April 9, 2021 Avid Medical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Part Number:VAMK024-03; Package GTIN: 20809160342500; Lot Number: 1445301 (Expiration Date: 04/30/2022) and 1445302 (Expiration Date: 04/30/2022)
  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:
Avid Medical, Inc.
Reason for Recall:
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. Under certain circumstances the applicator may grow Aspergillus penicillioides, which may result in a breach of the package integrity. A breach of package integrity may contaminate other components in AVID Medical kits.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

FISTULA (ON/OFF) ALL IN ONE BAG. Medical convenience kit, Avid Medical Part Number: VAMK024-03

Product Codes/Lot Numbers:

Part Number:VAMK024-03; Package GTIN: 20809160342500; Lot Number: 1445301 (Expiration Date: 04/30/2022) and 1445302 (Expiration Date: 04/30/2022)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1786-2021

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