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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00929-1
Product Name/Description Arthrex and Andreas Hettich Rotofix 32A Centrifuge, An in vitro diagnostic medical device (IVD)

Product Code: ABS-10020

Serial numbers: 14843 to 15070 and 15360 to 15559

Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 12/09/2012
Responsible Entity Device Technologies Australia Pty Ltd
Reason/Issue It has been identified that affected serial numbers may be able to be opened during centrifugation due to a manufacturing fault of the upper parts, resulting in affected units will have a higher bending edge (i.e. the hole for the emergency release pin is lower than it should be).
Recall Action Recall for Product Correction
Recall Action Instructions Customers to inspect all units as per the instructions provided in the recall notice and isolate any affected units. Sponsor will replace upper housing of affected centrifuges.
Contact Information 1800 429 551 - Device Technologies Regulatory Affairs