| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01421-1 |
| Product Name/Description |
Allen Medical Bow Frame
Model number: A-70800
Serial number range: A402596 thru to A543137
ARTG Number: 206820 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Allen Medical has become aware of a potential risk, which could result in critical harm to the patient if the base of the bow frame were to crack during use. Since the introduction of this product in March 2017, one complaint with no injury has been reported where the base of the frame cracked as the patient was being prepared for surgery. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Allen Medical is advising users to remove affected bow frames from use, until the units are corrected.
This action has been closed on the 14/09/2018 |
| Contact Information |
1800 336 937 - Denyers Pty Ltd T/a Denyers International |