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U.S. Department of Health and Human Services

Medical Devices

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Hettich Instruments Management I, Hettich Centrifuges with 2050 and 2076 Plastic Rotors

Recall Class: Class I

Recall Date Initiated: November 21, 2009

Products:

201424-01 Haematokrit 20 centrifuge with 2050 haematocrit rotor
2004-01 Mikro 20 centrifuge with 2076 haematocrit rotor
2070 Mikro 12-24 centrifuge with 2050 haematocrit rotor
2075 Haematokrit 24 centrifuge with 2050 haematocrit rotor

These centrifuges can be identified by reading the model number on the front or rear name tag. The rotors have the model numbers 2050 or 2076 stamped on them.

These devices were distributed from January, 1999 through November, 2009.

Use: The device separates the red blood cells from plasma to determine the patient’s hematocrit. A low hematocrit reading is a possible indicator of anemia.

Recalling Firm:

Hettich Instruments Management I
100 Cummings Center, Suite 130G
Beverly, Massachusetts 01915-6127

Reason for Recall:

The plastic centrifuge rotor may crack, break apart and be forcefully ejected through the plastic centrifuge housing at a high rate of speed. This may result in serious personal injury and damage to the surrounding area.

Public Contact:

The company may be contacted at 1-866-370-4388, Monday through Friday, 8:30 AM- 5:30 PM, Eastern Time.

FDA District: New England

FDA Comments:

On November 23, 2009, the company notified its customers by letter and email and:

  • described how to identify the recalled rotors
  • provided information to arrange for the return and replacement of the recalled rotors

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

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