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U.S. Department of Health and Human Services

Class 1 Device Recall Hettich Centrifuge Rotor

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 Class 1 Device Recall Hettich Centrifuge Rotorsee related information
Date Initiated by FirmNovember 21, 2009
Date PostedJanuary 21, 2010
Recall Status1 Terminated 3 on October 25, 2011
Recall NumberZ-0612-2010
Recall Event ID 53941
Product Classification Hematocrit Centrifuge - Product Code GKG
ProductMikro 12-24 Centrifuge with 2050 Rotor TYP #2070 and TYP 2070-01. Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured.
Code Information Units with plastic motor housing. TYP #2070 and TYP 2070-01 
FEI Number 3004578971
Recalling Firm/
Manufacturer		 Hettich Instruments Management I
100 Cummings Ctr Ste 130g
Beverly MA 01915-6127
Manufacturer Reason
for Recall		Centrifuge Rotor Failure: may crack, break, and explode outside the centrifuge.
FDA Determined
Cause 2		Device Design
ActionHettich Instruments notified Distributors by email on 11/21/09, to the Request For Urgent Action notifications, dated 11/23/2009. There is a description of how to identify a recalled rotor as well as a description of the replacement metal rotor that is to be used in place of the list of centrifuges affected by this recall. Customers are to cease using the setup described and contact their distributor or the firm. The firm will replace the plastic housing with a metal housing. Questions should be directed to 978-232-3957.
Quantity in Commerce46 units total
DistributionWorldwide Distribution -- USA, including states of CT and IN, and country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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