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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Hettich Centrifuges Issues a North America and Canada Recall of Plastic Hematocrit Rotors

Contact:
Darrall Pride
978-232-3957 x 110

FOR IMMEDIATE RELEASE - January 21, 2010 - Hettich Centrifuges, Beverly, MA, is initiating a North America and Canada recall of 2050 and 2076 plastic hematocrit rotors that are used in combination with the Mikro 12-24, Mikro 20, Haematokrit 20 and Haematokrit 24 bench top plastic centrifuges. These plastic rotors have the potential to break apart resulting in pieces of the rotor to be forcefully ejected through the plastic centrifuge housing. This may result in serious personal injury and damage to the surrounding area.

The recall includes the following models:

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

Customers who have the above listed centrifuge/rotor combination should immediately stop using the plastic rotors and immediately contact Hettich Instruments Management I to have these affected rotors replaced with metal rotors. The centrifuges can be identified by reading the model number on the front of the instrument or the name tag on the rear of the centrifuge; the rotors have the model numbers 2076 or 2050 stamped on them.

There has been one occurrence in the USA of the 2076 rotor breaking apart and pieces of the rotor destroying the centrifuge housing. The projectiles from this explosion caused damage to the surrounding area. There have been no injuries reported to date.

The rotors with centrifuge were distributed through Hettich scientific distributors in North America and Canada.

Hettich Centrifuges has notified its distributors and customers by letter and email on November 23, 2009 and is arranging for return and replacement of all recalled products.

Consumers with questions may contact the company at 1-866-370-4388 Monday through Friday from 8:30 am to 5:30 EST

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

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