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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01125-1
Product Name/Description Essure Permanent Birth Control
(Australasian Medical & Scientific Ltd - ESSURE System - Contraceptive, tubal occlusion, Insert)

Catalogue Number/Order Code: ESS305

All Batch Numbers

ARTG number 174123
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 28/08/2017
Responsible Entity Australasian Medical & Scientific Ltd
Reason/Issue AMSL is advising that all lots of Essure are being removed due to a temporary suspension of the European EC certificate during the European certificate renewal process. Further, post-market information suggests that some patients may not be fully informed of possible device & procedure related complications, including changes in menstrual bleeding, unintended pregnancy, chronic pain, perforation and migration of the device, allergy/hypersensitivity, or immune-type reactions.
Recall Action Hazard Alert
Recall Action Instructions AMSL is requesting Customers:
1.Inspect your stocks and quarantine all Essure kits and then email or call us so we may arrange for your stock to be recovered.
We require this information to reconcile this process.
2. If any of the recalled stock could have been possibly transferred from your hospital to another, please immediately let that hospital know of the recall action. It would be appreciated if you would then telephone us so that we can make contact with the hospital supplied from your hospital.
This notice should be forwarded to all those who need to be aware of this information within your organisation.

This action has been closed out on 19/11/2018
Contact Information 02 9882 3666 - AMSL