🔍 RecallPedia

GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The epidural route is recommended to provide anesthesia or administer analgesia for periods up to 96 hours. ..

Class I - Dangerous
🏥 Medical Devices Recalled: March 19, 2013 Hospira Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    List Numbers: 13086, 13087, 13088; Serial Numbers: All Serial Numbers
  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:
Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing the infusion rate set by their doctors. Patients are obtaining access to these codes via website sponsors by downloading the GemStar User/Service Manual featured on the sponsors' websites. The GemStar User/Service Manual should be removed from these w
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The epidural route is recommended to provide anesthesia or administer analgesia for periods up to 96 hours. ..

Product Codes/Lot Numbers:

List Numbers: 13086, 13087, 13088; Serial Numbers: All Serial Numbers

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0422-2015

Related Recalls

Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device.

Hospira

Class I - Dangerous

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 →