🔍 RecallPedia

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.

Class I - Dangerous
🏥 Medical Devices Recalled: December 12, 2022 Medtronic Perfusion Systems Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model BB811; Serial Number Range: 8111483548 - 8113999999; GTIN Number: 00643169178168 (Lot Numbers: 13386860, 13386998, 13387454, 223834103, 224773022, 224773023, 225467084, 225467085); GTIN Number: 00643169178175 (Lot Number: 13388339, 13389098, 13394289, 223815345, 223829391, 223834104, 223834105, 224602715, 224695594, 224702830, 224711400, 224773018, 224773019, 224773020, 224773021, 224875617, 224883237, 224893902)
  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:
Medtronic Perfusion Systems
Reason for Recall:
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.

Product Codes/Lot Numbers:

Model BB811; Serial Number Range: 8111483548 - 8113999999; GTIN Number: 00643169178168 (Lot Numbers: 13386860, 13386998, 13387454, 223834103, 224773022, 224773023, 225467084, 225467085); GTIN Number: 00643169178175 (Lot Number: 13388339, 13389098, 13394289, 223815345, 223829391, 223834104, 223834105, 224602715, 224695594, 224702830, 224711400, 224773018, 224773019, 224773020, 224773021, 224875617, 224883237, 224893902)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1023-2023

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