| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01286-1 |
| Product Name/Description |
EZ-Strip 145ìm (Assisted reproduction microtool)
Part Number: 7-72-1145/20
Lot Number: 150299-01
Expiry Date: June 2018 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/10/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been reported that an EZ-Strip product from the stated lot may contain debris that could result in the device failing to perform its intended purpose. This fault, if not identified by the customer could result in the loss of oocytes. |
| Recall Action |
Recall |
| Recall Action Instructions |
Key IVF Supplies are advising customers to cease use of the affected lot and immediately quarantine all remaining packs. Key IVF will arrange for the collection of the quarantined packs and will replace affected stock. This action has been closed-out on 02/03/2017. |
| Contact Information |
richard@keyivf.com |