Mikro 20 Centrifuge with 2076 Rotor TYP #2004 and TYP #2004-01. Used for the purpose of determining the hematocrit count

FDA device recall Z-0614-2010 · posted 2010-01-21 · Terminated

Recall details

Recalling firm

Hettich Instruments Management I

Reason for recall

Centrifuge Rotor Failure: may crack, break, and explode outside the centrifuge.

Action taken

Hettich 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.

Root cause

Device Design

Status

Terminated

Product code

GKG

Quantity affected

46 units total

Distribution

Worldwide Distribution -- USA, including states of CT and IN, and country of Canada.

Date initiated

2009-11-21

Date posted

2010-01-21

Date terminated

2011-10-25

Location

Beverly, MA