🔍 RecallPedia

The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.

Class I - Dangerous
🏥 Medical Devices Recalled: August 25, 2016 Natus Medical Incorporated Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    5045, 5046, 5047, 5048, 5051, 5053, 5056, 5057, 5096, 5097, 5128, 5129, 5130, 5131, 5132, 5133, 5134, 5135, 5136, 5138, 5139, 5209, 5210, 5211, 5212, 5213, 5214, 5219, 5220, 5221, 5222, 5223, 5224, 5225, 5226, 5227, 5228, 5248, 5249, 5250, 5251, 5252, 5253, 5254, 5255, 5256, 5257, 5276, 5277, 5278, 5279, 5280, 5281, 5282, 5283, 5284, 5285, 5286, 5287, 5288, 5289, 8290, 5291, 5292, 5293, 5294, 5322, 5323, 5324, 5325, 5326, 5327, 5328, 5329, 5330, 5331, 5332, 5333, 5334, 5335, 5336, 5337, 5383, 5385, 5388, 5389, 5504, 5505, 5506, 5507, 5508, 5509, 5510, 5511, 5543, 5544, 5545, 5546, 5547, 5548, 5549, 5550, 5551, and 5552.
  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:
Natus Medical Incorporated
Reason for Recall:
NatalCare LX incubators may have a defective base where the weld holding the wheel bushing to the tube is inadequate. There were several complaints of wheels bending out of alignment.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

The Medix NatalCare LX Intensive Care Incubator. Neonatal incubator. Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.

Product Codes/Lot Numbers:

5045, 5046, 5047, 5048, 5051, 5053, 5056, 5057, 5096, 5097, 5128, 5129, 5130, 5131, 5132, 5133, 5134, 5135, 5136, 5138, 5139, 5209, 5210, 5211, 5212, 5213, 5214, 5219, 5220, 5221, 5222, 5223, 5224, 5225, 5226, 5227, 5228, 5248, 5249, 5250, 5251, 5252, 5253, 5254, 5255, 5256, 5257, 5276, 5277, 5278, 5279, 5280, 5281, 5282, 5283, 5284, 5285, 5286, 5287, 5288, 5289, 8290, 5291, 5292, 5293, 5294, 5322, 5323, 5324, 5325, 5326, 5327, 5328, 5329, 5330, 5331, 5332, 5333, 5334, 5335, 5336, 5337, 5383, 5385, 5388, 5389, 5504, 5505, 5506, 5507, 5508, 5509, 5510, 5511, 5543, 5544, 5545, 5546, 5547, 5548, 5549, 5550, 5551, and 5552.

Distribution:

Distributed in: US, AL, CA, FL, IL, IN, KY, LA, MA, MS, NJ, NY, OK, PA, SC, VA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0056-2017

Related Recalls

The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically required for procedures such as ventriculostomy or intracranial pressure (ICP) monitoring. The various components of the kit are comprised to make it convenient for the practitioner to have all that they need in one place for fast and efficient intracranial access. cerebral spinal fluid (CSF).

Natus Medical Incorporated

Class I - Dangerous

Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable.

Nov 18, 2022 Diagnostic Equipment Nationwide View Details →