Recall Record

Bolton, N/A, United Kingdom

Medicina Uk Ltd recalls

1 recall recorded since 2018, most recently on 4 July 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
4 July 2022
Reason
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
Distribution
Nationwide
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0109-2023, Z-0107-2023, Z-0111-2023, Z-0108-2023, Z-0113-2023, Z-0110-2023, Z-0114-2023, Z-0112-2023

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.