🔍 RecallPedia

BodyGuard Microset, REF: A120-003XS2YV

Class I - Dangerous
🏥 Medical Devices Recalled: June 16, 2020 CME America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    All lots within expiry
  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:
CME America, LLC
Reason for Recall:
Infusion administration sets may have a delivery inaccuracy over plus/minus 13%, ranging from minus 42.8% to plus 17.5%. Use of the infusion pump system could cause over-infusion or under-infusion of therapy
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

BodyGuard Microset, REF: A120-003XS2YV

Product Codes/Lot Numbers:

All lots within expiry

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2575-2020

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Jul 30, 2020 Surgical Instruments Nationwide View Details →