FDA recall Z-0107-2023

Medicina Uk Ltd · Class II · device

Product

Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD

Reason for recall

Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

Distribution

Nationwide

Key facts

Status: Ongoing
Initiation date: 2022-07-04
Report date: 2022-10-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bolton, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0107-2023