Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device.

Class I - Dangerous
🏥 Medical Devices Recalled: August 2, 2012 Hospira Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    The letter was issued for all product presently in the field and product that will be released. Specific lot numbers were not indicated in the letter.
  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:
Hospira, Inc.
Reason for Recall:
Reports of leaking during filling and administration.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device.

Product Codes/Lot Numbers:

The letter was issued for all product presently in the field and product that will be released. Specific lot numbers were not indicated in the letter.

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2346-2012

Related Recalls

Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin Lock Collar, Non-DEHP, identified above due to a confirmed customer report of an occlusion of solvent in the male luer lock. This occlusion has the potential to prevent the set from being primed for use and cause a delay in therapy.

Feb 19, 2013 Other Medical Devices Nationwide View Details →