| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00697-1 |
| Product Name/Description |
STATLOCK IAB Stabilisation Device
(offers needle-free securement for intra-aortic balloon (IAB) catheters)
Macquet Part Number: 0065-00-0704
Products affected
All lot numbers from 3000001484 to 3000024495
ARTG Number: 139645 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
During post-quarantine packaging it was identified that the IFU for the STATLOCK Sheath Stabilisation Device for Percutaneous Sheath Introducers was erroneously packaged with the MEGA and SENSATION PLUS IAB Catheter Kits, instead of the IFU for the STATLOCK Catheter Stabilisation Device for IAB Catheters. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Maquet is advising users to inspect and identify the affected stocks. The IFU from the affected units should be removed and disposed prior to the use of the device. Affected customers can obtain a copy of the correct IFU by visiting the Maquet website at www.Maquet.com/statlockIFU , by scanning the QR code in the customer letter or by contacting the customer's local Maquet representative. This action has been closed-out on 11/05/2017. |
| Contact Information |
1800 605 824 - Director of Post-market |