| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00320-1 |
| Product Name/Description |
Omrix Pressure Regulators
(used to spray Evicel Solutions for Fibrin Sealent during open and laproscopic procedures to prevent bleeding)
Product Number: EVRC68 AND EVR54C
ARTG Number: 203072 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
22/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
The European Medicines Agency (EMA) has clarified their recommendation for 20 psi (as opposed to 20-25 psi) pressure to be used when spraying Evicel with the 45cm tip during laparoscopic surgery. As a result, the labelling of Omrix Pressure Regulators in Australia need to be updated and the sticker label on each Pressure Regulator will be replaced to reflect this change.
Also, in an effort to enhance consistency between the labelling of the Omrix Pressure Regulator and the Omrix Evicel Solutions for Sealant, the IFU for the Pressure Regulator has been updated to remove the following statement;
"Spray application of EVICEL should not be used in endoscopic procedures where the minimum recommended distance of 4 cm cannot be maintained. For laparoscopic procedures using accessory tips, see the recommendations in Table 2". |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Johnson & Johnson Medical (JJM) is providing users with the updated IFU and replacing stickers on the Omrix Pressure Regulators to reflect the new recommendation of 20psi when spraying Evicel with a 45cm tip during laparoscopic surgery. This action has been closed-out on 30/01/2017. |
| Contact Information |
02 9815 4000 - Johnson & Johnson Medical |