🔍 RecallPedia

CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a check valve, injection ports, 4-way stopcock, anti-siphon valve, roller clamp and tubing.

Class I - Dangerous
🏥 Medical Devices Recalled: August 30, 2013 CareFusion 303 Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 12086930, 12106215, 13016408, 13016834, 13025446, and 13025672.
  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:
CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a check valve, injection ports, 4-way stopcock, anti-siphon valve, roller clamp and tubing.

Product Codes/Lot Numbers:

Lot Numbers: 12086930, 12106215, 13016408, 13016834, 13025446, and 13025672.

Distribution:

Distributed in: IL

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2281-2013

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CareFusion 303

Class I - Dangerous

If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.

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CareFusion 303

Class I - Dangerous

Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

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