🔍 RecallPedia

Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.

Class I - Dangerous
🏥 Medical Devices Recalled: June 29, 2012 CareFusion 303 Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    All serial numbers associated with the Alaris Pump Module Model 8100: 8100 DEMO PUMP MODULE; 8100 Global Pump Module; 8100 IOC Pump Module V8.5.29.0; 8100 LVP Training Unit; 8100 Pump Module V8.5.29.0; 8100 Pump Module V8.5.29.0 (V9); Medley Patient Care System LVP; Model 8100 Trade-In Material; RCND 8100 Pump Module V8.5.29.0
  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:
CareFusion 303, Inc.
Reason for Recall:
The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module (model 8100) manufactured between August 2010 and July 2011.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.

Product Codes/Lot Numbers:

All serial numbers associated with the Alaris Pump Module Model 8100: 8100 DEMO PUMP MODULE; 8100 Global Pump Module; 8100 IOC Pump Module V8.5.29.0; 8100 LVP Training Unit; 8100 Pump Module V8.5.29.0; 8100 Pump Module V8.5.29.0 (V9); Medley Patient Care System LVP; Model 8100 Trade-In Material; RCND 8100 Pump Module V8.5.29.0

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2185-2012

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