FDA recall Z-0108-2023

Product

Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05

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-0108-2023