| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01645-1 |
| Product Name/Description |
Trauma RIA (Reamer/Irrigator/Aspirator) System
Part Affected; RIA Tube Assembly, for RIA Drive Shaft minimum length 520 mm, for No. 314.743, sterile
Part Number : 314.746S
Lot Numbers: 2251446-I, 2256902-I, 2256903-I, 2256904-I, 2256905-I, 2256906-I, 2256907-I
ARTG Number: 157016 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
The expiration date on the label for the referenced products is incorrect. Existing testing supports an expiration date of 2 years from manufacturing. The affected products on the market were labelled with an expiration date of 10 years. There is biocompatibility test data to support an expiration date 2 years only.
Use of this product beyond its expiry date of 2 years poses a theoretical risk of an adverse tissue reaction in the event the device develops cytotoxicity and/or infection. |
| Recall Action |
Recall |
| Recall Action Instructions |
Johnson & Johnson Medical (JJM) is requesting users Immediately inspect the device(s) in their possession to determine if your facility has affected product.
In the event defective product is identified please quarantine these units prior to returning them to JJM.
Return a copy of the completed acknowledgement form, even if no affected product is identified, by fax to 1800 241 101 or email to ra-jnjau-recallsanz@its.jnj.com
This action has been closed out on 18/02/2019 |
| Contact Information |
1300 562 711 - JJM Customer Service |