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Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

Class I - Dangerous
🏥 Medical Devices Recalled: November 26, 2012 Custom Healthcare Systems Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    LOT NO. 60812 EXPIRES: 11 /2012
  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:
Custom Healthcare Systems, Inc.
Reason for Recall:
Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

Product Codes/Lot Numbers:

LOT NO. 60812 EXPIRES: 11 /2012

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0797-2013

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