MicroSurgical Technology product recalled over sterility concerns

Recall date

September 17, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

MicroSurgical Technology Inc recalls Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps a…

Recall number

Z-0521-2025

FDA classification

Class II

Brand / firm

MicroSurgical Technology Inc

Sold / distributed

U.S.: CT, GA, MN, MT and TX. O.U.S.: Netherlands 24 total devices = 6 devices distributed in the United States and 18 devices distributed in Germany.

Why it was recalled

Due to pin coming off of handles.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Description: A MST Single Use Forceps or Scissors System consists of a reusable handle and one of a number of single use interchangeable heads. MST Single Use Forceps and Scissor heads are shipped ready to use sterile in a tray with Tyvek lid within a sterile pouch. MST Duet Reusable Handle for Single Use Forceps & Scissor Heads are supplied in a non-sterile condition and must be sterilized prior to and after every use. The blue sleeve the handle is packaged in is not intended to be sterilized and does not maintain sterility. Component: Yes. The MST Duet¿ Reusable Handle for Single Use Heads is the reusable handle component which connect to either Single Use Forceps or Scissors heads.