| 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 |
|
| 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 |